Raakhi Tripathi - Profile on Academia.edu (original) (raw)

Papers by Raakhi Tripathi

Research paper thumbnail of A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia

Cureus, Jul 14, 2023

Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to d... more Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-totreat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with Asthiposhak Tablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Asthiposhak Tablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bonespecific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.

Research paper thumbnail of An observational multi-centric COVID-19 sequelae study among health care workers

An observational multi-centric COVID-19 sequelae study among health care workers

The Lancet Regional Health - Southeast Asia

Research paper thumbnail of Antidepressant activity of Simvastatin in behavioral models of depression in rats

International Journal of Research in Medical Sciences, 2015

CAD) rates have increased during the last 30 years, whereas declining trends have been noticed in... more CAD) rates have increased during the last 30 years, whereas declining trends have been noticed in developed Western countries. 1 Various independent epidemiological studies 2 conducted in north India suggest that the prevalence of CAD has increased from 1% in 1960 to 10.5% in the urban population and a two fold increase in the rural population. 3 A higher prevalence of 7.4% was observed in some parts of rural South India. Among patients with CAD, hyperlipidemia is present in 2/3 rd of patients. 5 Statins are first line drugs for the treatment of hyperlipidemia. HMG -CoA reductase catalyzes the reaction which is the rate limiting step in cholesterol biosynthesis. Statins inhibit this enzyme and decreases cholesterol synthesis. This leads to increased hepatic LDL receptor activity and accelerate clearance of circulating LDL. Background: There is evidence, that statins can augment the antidepressant effects of fluoxetine in rats. Hence the present experimental study was designed to evaluate the effect of Simvastatin on duration of immobility in acute forced swim test (Acute FST) and Chronic forced swim test (Chronic FST), as models of behavioral despair in rats. Methods: In acute FST and Chronic FST models, effects of simvastatin (Smv) and fluoxetine (Flx) per se and in combination, on immobility of rats were compared. Open field test was performed to discriminate between the general behavioral stimulation and antidepressant effect of study drugs. Results: In Acute FST, duration of immobility decreased (171.33 ± 6.15 sec) non-significantly in simvastatin group, & decreased significantly in the groups of rats which received fluoxetine alone (161.33 ± 8.68, P < 0.01) or in combination with simvastatin (167.66 ± 7.71 sec, P < 0.001). The 3 treatment groups did not differ from each other. In chronic FST duration of immobility lowered significantly in both, the fluoxetine treated group (147.66 ± 8.73) and the combination treated group (130.5 ± 5.68 sec) with significant fall in the combination group (P < 0.001) compared to the individual therapy groups. Conclusions: Lowering cholesterol levels with statins not only reduces risks for cardiovascular events, but also affect serotonergic neurotransmission, leading to clinical efficacy of standard antidepressants. Simvastatin can augment the antidepressant effects of fluoxetine in rats, raising the possibility that statins could be used to facilitate the effects of antidepressants in humans.

Research paper thumbnail of A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance

A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance

Indian Journal of Pharmacology, 2019

OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on... more OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo. MATERIALS AND METHODS: A placebo-controlled, double-blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented volunteers (n = 60) were assigned randomly into two groups of study drug (3 g/day) or placebo (3 g/day) for 2 months. They were evaluated at days 0, 30, and 60 with physical stressors (6-min walk test [6MWT] – distance, HR, and BP; 6-min exercise test [6ETC] – distance, maximum and average speed; and fixed workload test [FWT] – systolic BP, diastolic BP [DBP], and HR on cycle ergometer) and Jammar's dynamometer test for handgrip strength test on each visit. RESULTS: In 6MWT in CB group, distance on day 30 (456 ± 42.1) and day 60 (468.3 ± 0.4) was significantly increased when compared with day 30 (422.6 ± 45.7) and day 60 (419.6 ± 45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92 ± 0.6 which was significantly more than that of placebo group 2.4 ± 0.6. On day 60, in FWT, DBP in the CB group was 75.8 ± 4.4 which was significantly low compared to the placebo group 82.4 ± 7.4 (P < 0.05). CONCLUSION: CB increased physical performance when exposed to AA even after one month and in case of UA increase in performance was seen when CB was administered for two months thus validating its adaptogenic (anti-stress) potential.

Research paper thumbnail of Antipsychotic Drug Utilization and Adverse Drug Reaction Profiling in Patients With Schizophrenia at a Tertiary Care Hospital in Western India

Cureus

Prescription pattern studies conducted in patients with schizophrenia have shown variability in t... more Prescription pattern studies conducted in patients with schizophrenia have shown variability in the utilization of antipsychotics based on the geographical location of the study setting. Moreover, there is only a sparse number of studies specifically related to adverse drug reactions (ADRs) in schizophrenia. Hence, a need was felt to study the antipsychotic utilization pattern and adverse drug reactions in patients with schizophrenia in our setting. This was a cross-sectional, observational study conducted at the psychiatry outpatient department (OPD) of a tertiary care hospital in India. Patients diagnosed to have schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) were included in the study provided they had been prescribed antipsychotic medications at the study center for at least three months. The sociodemographic profile of the patients and caregivers was recorded, and prescription pattern assessment was done using WHO core drug use indicators. Information related to ADRs was recorded, and further assessment was done based on the causality, severity, and preventability of ADRs. A total of 250 patients were enrolled in the study. Risperidone (40.25%) and olanzapine (26.32%) were the most commonly prescribed antipsychotic drugs, while trihexyphenidyl was the most frequently prescribed concomitant medication. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation, and weight gain were found to be the most common. The majority of ADRs were of mild severity in addition to being non-preventable. It was observed that atypical antipsychotics were commonly prescribed in the study center, and the majority of the ADRs were mild and not preventable, which shows the adequacy of prescribing practices in the current setting.

Research paper thumbnail of Online videos as a supplement tool to train II MBBS students in drug administration skills

Online videos as a supplement tool to train II MBBS students in drug administration skills

Journal of Pharmacology and Pharmacotherapeutics, 2019

Objective: To evaluate the effect of online videos along with traditional teaching on learning ph... more Objective: To evaluate the effect of online videos along with traditional teaching on learning pharmacotherapeutic skills. Materials and Methods: Eight videos illustrating skills required for drug administration by parenteral and inhalational routes were developed and uploaded along with additional resource materials on a dedicated website. Following an online pretest, two practicals on routes of drug administration were conducted for 181 II MBBS students. They were then allowed to voluntarily watch the videos. Video usage, change in knowledge (pre- and post-video observation test score), and performance (Objective Structured Clinical Examination [OSCE] scores of two internal assessments) and perceptions (using prevalidated questionnaire) were recorded. Results: The average number of videos watched/student was 7.50 ± 1.30, whereas the average number of times each video watched was 1.50 ± 0.094. Only 39 students watched the videos before the first internal assessment were found to have statistically higher OSCE score compared to others who failed to watch (P = 0.006). The latter group watched the videos subsequently and showed improvement in their OSCE scores in the second internal assessment as compared to the first one (14.28 ± 3.26; P = 0.001). Students (93.10%) perceived the online videos as useful teaching tools, which helped them to understand and retain the sequence of procedural steps of the skills better. Conclusion: Drug administration skills when taught using a blend of traditional teaching methods and online videos, improved the performance with added reinforcement. Student acceptability was high indicating online videos can serve as a supplementary tool.

Research paper thumbnail of Evaluation of student-symposium as a teaching- learning tool

Evaluation of student-symposium as a teaching- learning tool

Didactic lectures are traditionally most commonly used for teaching undergraduate medical student... more Didactic lectures are traditionally most commonly used for teaching undergraduate medical students. Some drawbacks of didactic lectures can be overcome by supplementing with novel teaching techniques. The current study was conducted to evaluate student-conducted symposium as a teaching learning tool in the subject of Pharmacology. Three symposia were conducted by randomly selected 20 students for each symposium, from a batch of 180 students of second year undergraduate medical students. The perception of students who conducted symposia and those who attended as audience was evaluated by using separate questionnaires. The performance was also assessed by giving a multiple choice question (MCQ) test.Students who got the opportunity to conduct symposium gave far more positive opinions about the teaching tool than those who passively attended the session. For example, 94% of the students conducting symposium opined that 'the knowledge acquired via this teaching...

Research paper thumbnail of Introduction of integrated lecture module: performance and perception of II year medical students

Background: Integration of subjects, facilitates acquisition of knowledge, skills and attitudes t... more Background: Integration of subjects, facilitates acquisition of knowledge, skills and attitudes to ‘theoretical’ subjects in a clinical context in comparison to traditional teaching. The utility of integrated lecture modules (ILM) was accordingly planned and the objective of the study was to evaluate the performance and to document the perception of year II MBBS students exposed to both the integrated and didactic lecture modules. Materials and Methods: The project was executed on 140 consented year II MBBS students who were randomly divided into 2 groups; group I (n=70) was exposed to didactic lecture (DLG), group II (n=70) to integrated lecture (ILG). The didactic lectures were taken by Pharmacology faculty, while integrated lectures by Pharmacology, Preventive and Social Medicine and Pediatrics faculty. Before the session, students appeared for a pretest consisting of 20 MCQs. Following the post test, the evaluation of the perception of students regarding this study was done by a...

Research paper thumbnail of Prescription Communication Using 5-R Framework

Prescription Communication Using 5-R Framework

Research paper thumbnail of Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Indian Journal of Pharmacology, 2016

Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challen... more Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. Materials and Methods: The module consisted of (a) e-mailing an ADR narrative and online filling of the “suspected ADR reporting form” (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012–2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013–2014. The evaluation consisted of recording the number of students responding and the scores achieved. Results: A total of 171 students in 2012–2013 batch and 179 in 2013–2014 batch participated. In the 2012–2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013–2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. Conclusion: This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

Research paper thumbnail of Assessment of prescribing pattern of drugs and completeness of prescriptions as per the World Health Organization prescribing indicators in various Indian tertiary care centers: A multicentric study by Rational Use of Medicines Centers-Indian Council of Medical Research network under National Vir...

Assessment of prescribing pattern of drugs and completeness of prescriptions as per the World Health Organization prescribing indicators in various Indian tertiary care centers: A multicentric study by Rational Use of Medicines Centers-Indian Council of Medical Research network under National Vir...

Indian Journal of Pharmacology, Dec 21, 2022

Research paper thumbnail of Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Journal of The Association of Physicians of India

Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the av... more Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; ...

Research paper thumbnail of A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective

Cureus, Jan 31, 2023

Clinical trial regulations for new drugs in India released a gazette notification for obtaining a... more Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.

Research paper thumbnail of Use of drugs not listed in the National List of Essential Medicines: Findings from a prescription analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in tertiary care hospitals across India

Use of drugs not listed in the National List of Essential Medicines: Findings from a prescription analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in tertiary care hospitals across India

Indian Journal of Pharmacology, Feb 2, 2023

Research paper thumbnail of A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures

A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures

Cureus

Research paper thumbnail of Evaluation of Antidepressant Effect of Minocycline in Alcohol Abstinence-Induced Depression Model in Mice

Cureus

Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. ... more Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. Also, alcohol withdrawal induces depression and anxiety, which is associated with relapse in alcohol consumption. Minocycline, a tetracycline derivative, has shown an antidepressant effect in preclinical models. However, their effect on alcohol withdrawal-induced depression has not been studied. Therefore, the current study has been undertaken to evaluate the effect of minocycline on alcohol abstinence-induced depression models in mice. Method We conducted the study in two models. C57bl/6 mice were given a two-bottle choice (alcohol + water) for 28 days. During alcohol abstinence of 14 days, mice were treated with 10 mg/kg, 30 mg/kg, and 50 mg/kg of minocycline and were evaluated for behavioral changes using the forced swim test (FST) and tail suspension test (TST). A sucrose preference test was carried out where mice were exposed to binge alcohol drinking protocol for 12 days, where a two-bottle choice (alcohol or water) was given. This was followed by exposing the mice to a two-bottle choice paradigm (alcohol + sucrose) and they were divided into groups-no treatment group, vehicle-treated, minocycline 30 mg/kg or minocycline 50 mg/kg treated-and consumption of sucrose was assessed. Result In the forced swim test, a significant decrease in immobility time (p<0.05) was observed in the high-dose minocycline group (82.75±19.09) as compared to the vehicle control group (128.12±35.44). In the tail suspension test also, a significant decrease in immobility time (p<0.05) was seen in the high-dose minocycline group (83.75±18.61) as compared to the vehicle control group (122.25±18.51). The water and alcohol intake were comparable among all groups. In the sucrose preference test, it was found that the minocycline 50 mg/kg group had the highest sucrose preference (55%) followed by the minocycline 30 mg/kg group (50%) as compared to 42% in the vehicle control group. Significant reduction in brain-derived neurotrophic factor (BDNF) levels was seen with minocycline 50 mg/kg (p<0.05) and minocycline 30 mg/kg group (p<0.05) in BDNF levels when compared to the normal control group. Conclusion Minocycline in a higher dose (50 mg/kg) has shown an effect in alcohol withdrawal-induced depression in the abstinence-induced two-bottle choice model in mice. Both doses of minocycline have shown an effect in the sucrose preference test in the alcohol withdrawal-induced depression model.

Research paper thumbnail of S‐adenosyl methionine improves motor co‐ordination with reduced oxidative stress, dopaminergic neuronal loss, and DNA methylation in the brain striatum of 6‐hydroxydopamine‐induced neurodegeneration in rats

S‐adenosyl methionine improves motor co‐ordination with reduced oxidative stress, dopaminergic neuronal loss, and DNA methylation in the brain striatum of 6‐hydroxydopamine‐induced neurodegeneration in rats

The Anatomical Record

PURPOSE Parkinson's disease (PD) is the most common age-related neurodegenerative disease wor... more PURPOSE Parkinson's disease (PD) is the most common age-related neurodegenerative disease worldwide. S-adenosyl methionine (SAMe), a methyl donor that plays an important role in DNA methylation, could replenish the cellular antioxidant glutathione (GSH). Herein, we investigated the neuroprotective effects of SAMe in 6-hydroxydopamine (6-OHDA) rat models of PD and elucidated the underlying mechanism. METHODS PD model rats were developed by injecting 6-OHDA stereotaxically into the striatum. In Phase 1 of the study, we performed the neurobehavioral tests, GSH assay, and histopathology to evaluate the neuroprotective effects of SAMe. The animals were treated with SAMe (150 or 300 mg/kg body weight) orally for 28 days. The positive control group received selegiline (5 mg/kg), whereas the disease control group received normal saline. In Phase 2, we evaluated the striatal dopamine levels and performed DNA methylation assay to uncover the mechanism of action of SAMe. In this phase, a higher dose of SAMe (300 mg/kg) was used. RESULTS SAMe (300 mg/kg) treatment for 4 weeks significantly attenuated the abnormal circling behavior in PD rats (p < 0.05). Moreover, SAMe at both doses (150 and 300 mg/kg) enhanced the performance of PD rats in the open field test and stepping test (p < 0.05). SAMe treatment significantly increased the GSH levels, and at high dose, SAMe restricted neuronal loss in the striatum of PD-model rats (p < 0.05). Moreover, SAMe treatment led to a significant recovery in the dopamine levels and improved the DNA methylation status in the dopaminergic neurons (p < 0.05) of PD model rats. CONCLUSION SAMe exhibits antioxidant activity and DNA methylation modulating effects in 6-OHDA model PD rats. Moreover, SAMe prevents neuronal loss in PD rats suggesting that SAMe has therapeutic potential in preventing PD development. The neuroprotective potential of SAMe is greater at high doses.

Research paper thumbnail of Evaluation of Learning and Memory of Celecoxib and It's Combination With Antiepileptic Drug in Pentylenetetrazole Induced Kindling Model in Rats

Evaluation of Learning and Memory of Celecoxib and It's Combination With Antiepileptic Drug in Pentylenetetrazole Induced Kindling Model in Rats

Social Science Research Network, 2021

Research paper thumbnail of A.S.P.I.R.E: A student led initiative to foster a facilitative environment for undergraduate medical research

A.S.P.I.R.E: A student led initiative to foster a facilitative environment for undergraduate medical research

Perspectives in Clinical Research, 2022

Research paper thumbnail of Student Perception of Reinforcing Learning Model. Perception of Medical Students towards Teaching of Pharmacology through Reinforcing Learning Model

Student Perception of Reinforcing Learning Model. Perception of Medical Students towards Teaching of Pharmacology through Reinforcing Learning Model

Background: There is need of novel methods of teaching subject of pharmacology, which will increa... more Background: There is need of novel methods of teaching subject of pharmacology, which will increase curiosity and retention of knowledge. At the same time, the new method should be student friendly and well accepted. Hence reinforcing learning model (RLM) was developed and current study is conducted to assess perception of students about this method. Methodology: The perception of students was assessed on Likert scale using a 15 point questionnaire. The data was analysed descriptively. Results: Majority of the students (more than 50 %) gave favourable opinion about the module. Majority of them gave neutral opinion (40 %) when asked whether the session should be optional in the curriculum. Conclusion: RLM followed by discussion can be a valuable tool to reinforce didactic method of teaching pharmacology. [Sarkate P NJIRM 2015; 6(2):101-104] Introduction: Pharmacology is a vast, ever expanding and volatile subject. There is a need to supplement the traditional teaching learning method...

Research paper thumbnail of A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia

Cureus, Jul 14, 2023

Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to d... more Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-totreat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with Asthiposhak Tablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Asthiposhak Tablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bonespecific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.

Research paper thumbnail of An observational multi-centric COVID-19 sequelae study among health care workers

An observational multi-centric COVID-19 sequelae study among health care workers

The Lancet Regional Health - Southeast Asia

Research paper thumbnail of Antidepressant activity of Simvastatin in behavioral models of depression in rats

International Journal of Research in Medical Sciences, 2015

CAD) rates have increased during the last 30 years, whereas declining trends have been noticed in... more CAD) rates have increased during the last 30 years, whereas declining trends have been noticed in developed Western countries. 1 Various independent epidemiological studies 2 conducted in north India suggest that the prevalence of CAD has increased from 1% in 1960 to 10.5% in the urban population and a two fold increase in the rural population. 3 A higher prevalence of 7.4% was observed in some parts of rural South India. Among patients with CAD, hyperlipidemia is present in 2/3 rd of patients. 5 Statins are first line drugs for the treatment of hyperlipidemia. HMG -CoA reductase catalyzes the reaction which is the rate limiting step in cholesterol biosynthesis. Statins inhibit this enzyme and decreases cholesterol synthesis. This leads to increased hepatic LDL receptor activity and accelerate clearance of circulating LDL. Background: There is evidence, that statins can augment the antidepressant effects of fluoxetine in rats. Hence the present experimental study was designed to evaluate the effect of Simvastatin on duration of immobility in acute forced swim test (Acute FST) and Chronic forced swim test (Chronic FST), as models of behavioral despair in rats. Methods: In acute FST and Chronic FST models, effects of simvastatin (Smv) and fluoxetine (Flx) per se and in combination, on immobility of rats were compared. Open field test was performed to discriminate between the general behavioral stimulation and antidepressant effect of study drugs. Results: In Acute FST, duration of immobility decreased (171.33 ± 6.15 sec) non-significantly in simvastatin group, & decreased significantly in the groups of rats which received fluoxetine alone (161.33 ± 8.68, P < 0.01) or in combination with simvastatin (167.66 ± 7.71 sec, P < 0.001). The 3 treatment groups did not differ from each other. In chronic FST duration of immobility lowered significantly in both, the fluoxetine treated group (147.66 ± 8.73) and the combination treated group (130.5 ± 5.68 sec) with significant fall in the combination group (P < 0.001) compared to the individual therapy groups. Conclusions: Lowering cholesterol levels with statins not only reduces risks for cardiovascular events, but also affect serotonergic neurotransmission, leading to clinical efficacy of standard antidepressants. Simvastatin can augment the antidepressant effects of fluoxetine in rats, raising the possibility that statins could be used to facilitate the effects of antidepressants in humans.

Research paper thumbnail of A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance

A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance

Indian Journal of Pharmacology, 2019

OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on... more OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo. MATERIALS AND METHODS: A placebo-controlled, double-blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented volunteers (n = 60) were assigned randomly into two groups of study drug (3 g/day) or placebo (3 g/day) for 2 months. They were evaluated at days 0, 30, and 60 with physical stressors (6-min walk test [6MWT] – distance, HR, and BP; 6-min exercise test [6ETC] – distance, maximum and average speed; and fixed workload test [FWT] – systolic BP, diastolic BP [DBP], and HR on cycle ergometer) and Jammar's dynamometer test for handgrip strength test on each visit. RESULTS: In 6MWT in CB group, distance on day 30 (456 ± 42.1) and day 60 (468.3 ± 0.4) was significantly increased when compared with day 30 (422.6 ± 45.7) and day 60 (419.6 ± 45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92 ± 0.6 which was significantly more than that of placebo group 2.4 ± 0.6. On day 60, in FWT, DBP in the CB group was 75.8 ± 4.4 which was significantly low compared to the placebo group 82.4 ± 7.4 (P < 0.05). CONCLUSION: CB increased physical performance when exposed to AA even after one month and in case of UA increase in performance was seen when CB was administered for two months thus validating its adaptogenic (anti-stress) potential.

Research paper thumbnail of Antipsychotic Drug Utilization and Adverse Drug Reaction Profiling in Patients With Schizophrenia at a Tertiary Care Hospital in Western India

Cureus

Prescription pattern studies conducted in patients with schizophrenia have shown variability in t... more Prescription pattern studies conducted in patients with schizophrenia have shown variability in the utilization of antipsychotics based on the geographical location of the study setting. Moreover, there is only a sparse number of studies specifically related to adverse drug reactions (ADRs) in schizophrenia. Hence, a need was felt to study the antipsychotic utilization pattern and adverse drug reactions in patients with schizophrenia in our setting. This was a cross-sectional, observational study conducted at the psychiatry outpatient department (OPD) of a tertiary care hospital in India. Patients diagnosed to have schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) were included in the study provided they had been prescribed antipsychotic medications at the study center for at least three months. The sociodemographic profile of the patients and caregivers was recorded, and prescription pattern assessment was done using WHO core drug use indicators. Information related to ADRs was recorded, and further assessment was done based on the causality, severity, and preventability of ADRs. A total of 250 patients were enrolled in the study. Risperidone (40.25%) and olanzapine (26.32%) were the most commonly prescribed antipsychotic drugs, while trihexyphenidyl was the most frequently prescribed concomitant medication. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation, and weight gain were found to be the most common. The majority of ADRs were of mild severity in addition to being non-preventable. It was observed that atypical antipsychotics were commonly prescribed in the study center, and the majority of the ADRs were mild and not preventable, which shows the adequacy of prescribing practices in the current setting.

Research paper thumbnail of Online videos as a supplement tool to train II MBBS students in drug administration skills

Online videos as a supplement tool to train II MBBS students in drug administration skills

Journal of Pharmacology and Pharmacotherapeutics, 2019

Objective: To evaluate the effect of online videos along with traditional teaching on learning ph... more Objective: To evaluate the effect of online videos along with traditional teaching on learning pharmacotherapeutic skills. Materials and Methods: Eight videos illustrating skills required for drug administration by parenteral and inhalational routes were developed and uploaded along with additional resource materials on a dedicated website. Following an online pretest, two practicals on routes of drug administration were conducted for 181 II MBBS students. They were then allowed to voluntarily watch the videos. Video usage, change in knowledge (pre- and post-video observation test score), and performance (Objective Structured Clinical Examination [OSCE] scores of two internal assessments) and perceptions (using prevalidated questionnaire) were recorded. Results: The average number of videos watched/student was 7.50 ± 1.30, whereas the average number of times each video watched was 1.50 ± 0.094. Only 39 students watched the videos before the first internal assessment were found to have statistically higher OSCE score compared to others who failed to watch (P = 0.006). The latter group watched the videos subsequently and showed improvement in their OSCE scores in the second internal assessment as compared to the first one (14.28 ± 3.26; P = 0.001). Students (93.10%) perceived the online videos as useful teaching tools, which helped them to understand and retain the sequence of procedural steps of the skills better. Conclusion: Drug administration skills when taught using a blend of traditional teaching methods and online videos, improved the performance with added reinforcement. Student acceptability was high indicating online videos can serve as a supplementary tool.

Research paper thumbnail of Evaluation of student-symposium as a teaching- learning tool

Evaluation of student-symposium as a teaching- learning tool

Didactic lectures are traditionally most commonly used for teaching undergraduate medical student... more Didactic lectures are traditionally most commonly used for teaching undergraduate medical students. Some drawbacks of didactic lectures can be overcome by supplementing with novel teaching techniques. The current study was conducted to evaluate student-conducted symposium as a teaching learning tool in the subject of Pharmacology. Three symposia were conducted by randomly selected 20 students for each symposium, from a batch of 180 students of second year undergraduate medical students. The perception of students who conducted symposia and those who attended as audience was evaluated by using separate questionnaires. The performance was also assessed by giving a multiple choice question (MCQ) test.Students who got the opportunity to conduct symposium gave far more positive opinions about the teaching tool than those who passively attended the session. For example, 94% of the students conducting symposium opined that 'the knowledge acquired via this teaching...

Research paper thumbnail of Introduction of integrated lecture module: performance and perception of II year medical students

Background: Integration of subjects, facilitates acquisition of knowledge, skills and attitudes t... more Background: Integration of subjects, facilitates acquisition of knowledge, skills and attitudes to ‘theoretical’ subjects in a clinical context in comparison to traditional teaching. The utility of integrated lecture modules (ILM) was accordingly planned and the objective of the study was to evaluate the performance and to document the perception of year II MBBS students exposed to both the integrated and didactic lecture modules. Materials and Methods: The project was executed on 140 consented year II MBBS students who were randomly divided into 2 groups; group I (n=70) was exposed to didactic lecture (DLG), group II (n=70) to integrated lecture (ILG). The didactic lectures were taken by Pharmacology faculty, while integrated lectures by Pharmacology, Preventive and Social Medicine and Pediatrics faculty. Before the session, students appeared for a pretest consisting of 20 MCQs. Following the post test, the evaluation of the perception of students regarding this study was done by a...

Research paper thumbnail of Prescription Communication Using 5-R Framework

Prescription Communication Using 5-R Framework

Research paper thumbnail of Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Indian Journal of Pharmacology, 2016

Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challen... more Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. Materials and Methods: The module consisted of (a) e-mailing an ADR narrative and online filling of the “suspected ADR reporting form” (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012–2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013–2014. The evaluation consisted of recording the number of students responding and the scores achieved. Results: A total of 171 students in 2012–2013 batch and 179 in 2013–2014 batch participated. In the 2012–2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013–2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. Conclusion: This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

Research paper thumbnail of Assessment of prescribing pattern of drugs and completeness of prescriptions as per the World Health Organization prescribing indicators in various Indian tertiary care centers: A multicentric study by Rational Use of Medicines Centers-Indian Council of Medical Research network under National Vir...

Assessment of prescribing pattern of drugs and completeness of prescriptions as per the World Health Organization prescribing indicators in various Indian tertiary care centers: A multicentric study by Rational Use of Medicines Centers-Indian Council of Medical Research network under National Vir...

Indian Journal of Pharmacology, Dec 21, 2022

Research paper thumbnail of Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Journal of The Association of Physicians of India

Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the av... more Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; ...

Research paper thumbnail of A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective

Cureus, Jan 31, 2023

Clinical trial regulations for new drugs in India released a gazette notification for obtaining a... more Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.

Research paper thumbnail of Use of drugs not listed in the National List of Essential Medicines: Findings from a prescription analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in tertiary care hospitals across India

Use of drugs not listed in the National List of Essential Medicines: Findings from a prescription analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in tertiary care hospitals across India

Indian Journal of Pharmacology, Feb 2, 2023

Research paper thumbnail of A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures

A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures

Cureus

Research paper thumbnail of Evaluation of Antidepressant Effect of Minocycline in Alcohol Abstinence-Induced Depression Model in Mice

Cureus

Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. ... more Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. Also, alcohol withdrawal induces depression and anxiety, which is associated with relapse in alcohol consumption. Minocycline, a tetracycline derivative, has shown an antidepressant effect in preclinical models. However, their effect on alcohol withdrawal-induced depression has not been studied. Therefore, the current study has been undertaken to evaluate the effect of minocycline on alcohol abstinence-induced depression models in mice. Method We conducted the study in two models. C57bl/6 mice were given a two-bottle choice (alcohol + water) for 28 days. During alcohol abstinence of 14 days, mice were treated with 10 mg/kg, 30 mg/kg, and 50 mg/kg of minocycline and were evaluated for behavioral changes using the forced swim test (FST) and tail suspension test (TST). A sucrose preference test was carried out where mice were exposed to binge alcohol drinking protocol for 12 days, where a two-bottle choice (alcohol or water) was given. This was followed by exposing the mice to a two-bottle choice paradigm (alcohol + sucrose) and they were divided into groups-no treatment group, vehicle-treated, minocycline 30 mg/kg or minocycline 50 mg/kg treated-and consumption of sucrose was assessed. Result In the forced swim test, a significant decrease in immobility time (p<0.05) was observed in the high-dose minocycline group (82.75±19.09) as compared to the vehicle control group (128.12±35.44). In the tail suspension test also, a significant decrease in immobility time (p<0.05) was seen in the high-dose minocycline group (83.75±18.61) as compared to the vehicle control group (122.25±18.51). The water and alcohol intake were comparable among all groups. In the sucrose preference test, it was found that the minocycline 50 mg/kg group had the highest sucrose preference (55%) followed by the minocycline 30 mg/kg group (50%) as compared to 42% in the vehicle control group. Significant reduction in brain-derived neurotrophic factor (BDNF) levels was seen with minocycline 50 mg/kg (p<0.05) and minocycline 30 mg/kg group (p<0.05) in BDNF levels when compared to the normal control group. Conclusion Minocycline in a higher dose (50 mg/kg) has shown an effect in alcohol withdrawal-induced depression in the abstinence-induced two-bottle choice model in mice. Both doses of minocycline have shown an effect in the sucrose preference test in the alcohol withdrawal-induced depression model.

Research paper thumbnail of S‐adenosyl methionine improves motor co‐ordination with reduced oxidative stress, dopaminergic neuronal loss, and DNA methylation in the brain striatum of 6‐hydroxydopamine‐induced neurodegeneration in rats

S‐adenosyl methionine improves motor co‐ordination with reduced oxidative stress, dopaminergic neuronal loss, and DNA methylation in the brain striatum of 6‐hydroxydopamine‐induced neurodegeneration in rats

The Anatomical Record

PURPOSE Parkinson's disease (PD) is the most common age-related neurodegenerative disease wor... more PURPOSE Parkinson's disease (PD) is the most common age-related neurodegenerative disease worldwide. S-adenosyl methionine (SAMe), a methyl donor that plays an important role in DNA methylation, could replenish the cellular antioxidant glutathione (GSH). Herein, we investigated the neuroprotective effects of SAMe in 6-hydroxydopamine (6-OHDA) rat models of PD and elucidated the underlying mechanism. METHODS PD model rats were developed by injecting 6-OHDA stereotaxically into the striatum. In Phase 1 of the study, we performed the neurobehavioral tests, GSH assay, and histopathology to evaluate the neuroprotective effects of SAMe. The animals were treated with SAMe (150 or 300 mg/kg body weight) orally for 28 days. The positive control group received selegiline (5 mg/kg), whereas the disease control group received normal saline. In Phase 2, we evaluated the striatal dopamine levels and performed DNA methylation assay to uncover the mechanism of action of SAMe. In this phase, a higher dose of SAMe (300 mg/kg) was used. RESULTS SAMe (300 mg/kg) treatment for 4 weeks significantly attenuated the abnormal circling behavior in PD rats (p < 0.05). Moreover, SAMe at both doses (150 and 300 mg/kg) enhanced the performance of PD rats in the open field test and stepping test (p < 0.05). SAMe treatment significantly increased the GSH levels, and at high dose, SAMe restricted neuronal loss in the striatum of PD-model rats (p < 0.05). Moreover, SAMe treatment led to a significant recovery in the dopamine levels and improved the DNA methylation status in the dopaminergic neurons (p < 0.05) of PD model rats. CONCLUSION SAMe exhibits antioxidant activity and DNA methylation modulating effects in 6-OHDA model PD rats. Moreover, SAMe prevents neuronal loss in PD rats suggesting that SAMe has therapeutic potential in preventing PD development. The neuroprotective potential of SAMe is greater at high doses.

Research paper thumbnail of Evaluation of Learning and Memory of Celecoxib and It's Combination With Antiepileptic Drug in Pentylenetetrazole Induced Kindling Model in Rats

Evaluation of Learning and Memory of Celecoxib and It's Combination With Antiepileptic Drug in Pentylenetetrazole Induced Kindling Model in Rats

Social Science Research Network, 2021

Research paper thumbnail of A.S.P.I.R.E: A student led initiative to foster a facilitative environment for undergraduate medical research

A.S.P.I.R.E: A student led initiative to foster a facilitative environment for undergraduate medical research

Perspectives in Clinical Research, 2022

Research paper thumbnail of Student Perception of Reinforcing Learning Model. Perception of Medical Students towards Teaching of Pharmacology through Reinforcing Learning Model

Student Perception of Reinforcing Learning Model. Perception of Medical Students towards Teaching of Pharmacology through Reinforcing Learning Model

Background: There is need of novel methods of teaching subject of pharmacology, which will increa... more Background: There is need of novel methods of teaching subject of pharmacology, which will increase curiosity and retention of knowledge. At the same time, the new method should be student friendly and well accepted. Hence reinforcing learning model (RLM) was developed and current study is conducted to assess perception of students about this method. Methodology: The perception of students was assessed on Likert scale using a 15 point questionnaire. The data was analysed descriptively. Results: Majority of the students (more than 50 %) gave favourable opinion about the module. Majority of them gave neutral opinion (40 %) when asked whether the session should be optional in the curriculum. Conclusion: RLM followed by discussion can be a valuable tool to reinforce didactic method of teaching pharmacology. [Sarkate P NJIRM 2015; 6(2):101-104] Introduction: Pharmacology is a vast, ever expanding and volatile subject. There is a need to supplement the traditional teaching learning method...