A randomized controlled exploratory evaluation of standardized Ayurvedic formulations in symptomatic osteoarthritis knees: A Government Of India NMITLI … (original) (raw)
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Evidence-based complementary and alternative medicine : eCAM, 2011
The multidisciplinary "New Millennium Indian Technology Leadership Initiative" Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base of Zingiber officinale and Tinospora cordifolia with a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences (P < .05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P < .05) least analgesic consumption and improved knee status, "C" formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.
Herbal medicines for the treatment of osteoarthritis: a systematic review
Focus on Alternative and Complementary Therapies, 2010
To systematically review all randomised controlled trials (RCTs) on the effectiveness of herbal medicines and plant extracts, which are either taken orally or applied topically, for osteoarthritis. Searching MEDLINE, EMBASE, BIOSIS Previews, CINAHL and the Cochrane Library were searched from their inception to May 2000. The search terms used were 'osteoarthritis', 'osteoarthrosis', 'degenerative joint disease', 'degenerative arthritis', 'degenerative arthrosis', 'gonarthrosis', 'coxarthrosis', 'botanic', 'phyto', 'herb', and all derivatives, together with individual plant and herb names. The bibliographies of the retrieved studies and reviews, and the authors' own files were also examined. Experts and manufacturers were contacted for published or unpublished studies. Study selection Study designs of evaluations included in the review RCTs and systematic reviews were eligible for inclusion. Specific interventions included in the review Comparative studies of one herbal treatment measured against another active drug were included, as were relevant systematic reviews. Parenteral herbal preparations were excluded. The studies in the review examined: Articulin-F (an ayurvedic herbomineral formulation containing 450 mg Withania somnifera root, 100 mg Boswellia serrata oleo-gum resin, 50 mg Curcoma longa rhizome, and 50 mg zinc) compared with placebo; a mixture (1:3 or 2:3) of avocado and soybean unsaponifiables (ASU) compared with placebo; capsaicin cream compared with placebo or vehicle cream; Devil's claw (Harpagophytum procumbens, 670 to 800 mg, three times daily) compared with placebo; Eazmov 50 mg (an ayurvedic herbal preparation containing Cyperus rotundus, Tinosporda cordifolia, Saussurea lappa, Picrorrhiza kurrow and Zingiber officiniale) compared with 50 mg diclofenac; ginger extract (170 mg Eurovita extract 33, three times daily) compared with ibuprofen and placebo; Gitadyl (a herbal preparation containing 110 mg feverfew, 90 mg American aspen, and 60 mg milfoil) compared with ibuprofen; Phytodolor (a fixed herbal preparation containing alcoholic extracts of Populus tremula, Fraxinus excelsior and Solidago virgaurea; 30 or 40 drops, three times daily) compared with diclofenac 25 mg, three times daily, placebo or piroxicam (20 mg/day); Reumalex (a herbal medicine containing 100 mg Pulv White Willow bark, 40 mg Pulv Guaiacum Resin BHP, 35 mg Pulv Black Cohosh BHP, 25 mg Pulv Ext Sarsparilla 4:1 and 17 mg Pulv Ext Poplar Bark 7:1) equivalent to 20 to 40mg/day salicylic acid compared with placebo; stinging nettle leaf compared with white deadnettle leaf. The duration of the treatments ranged from 2 weeks to 6 months. Trials lacking in methodological details such as dosage descriptions were excluded.
International Journal of Ayurvedic Medicine
Background: 20% to30 % elderly population suffers with Musculoskeletal disorders such as Multiple joint pains, Low back pain, Rheumatoid arthritis, Osteoarthritis. Multiple treatment modalities are in vogue to treat MSDs all over the world but neither provides adequate pain relief nor modifies the disease process. Hence majority of the tribal population prefer traditional healers for treating MSDs as they are safe, effective, inexpensive and easily available. Aim & Objectives: Quantitative analysis of Medicinal plants used by the traditional healers of Karanja block of Wardha district for treating musculoskeletal disorders. Material & Methods: The survey study was carried out through field visits. Questionnaire, personal interviews and discussions with the traditional healers were used for data collection. Specific pharmacological properties of herbal drugs used by the traditional healers to treat MSDs were authenticated by taxonomist and forest range officer and verified through Ni...
Study of a Standardized Plant Extract Used as an Anti-Inflammatory Drug to Reduce Joint Pain
Revista De Chimie, 2020
This study was to demonstrate the role of a natural anti-inflammatory, in reducing pain, inflammatory process and increasing joint mobility in elderly patients diagnosed with knee osteoarthritis. Osteoarthritis off knee affect the articular cartilage, but also the articular capsule, leading to disability. This natural anti-inflammatory has a complex composition: extract de Boswellia serrata 300 mg, extract de curcuma 100 mg, extract Pinus pinaster 80 mg și extract de Zingiber officinale 40 mg. The combination of herbal products, which have no side effects, with electrotherapy and kinetotherapy can be a real success in this category of patients, also influencing their well-being.
Background: Knee osteoarthritis (KOA) is the most common form of arthritis, causing disability and impaired quality of life especially in the elderly. Sri Lankan traditional medicine (STM) is widely used to treat OA, but no clinical trial evaluated on STM regimens for KOA to discuss their safety and efficacy in the treatment. The aim of this study is to compare the efficacy and safety of STM regimen for KOA in comparison to recommended conventional pain management therapy over a period of 8 weeks on relieving the condition. Study design: This is a clinical trial following a protocol-driven open-labeled randomized controlled study enrolling patients with KOA that will be conducted as a single-center trial in the National Ayurveda Teaching Hospital, Sri Lanka. Rasnadvigunabhagasaya herbal decoction (RDBD) and an herbal pill Yoaraja Guggulu were selected as the rescue medication for treating joint disorders. The two Ayurvedic dosage forms will be tested against the non-steroidal anti-inflammatory drugs tab paracetamol and tab ibuprofen as the rescue medication for their safety and efficacy. As test products for external application, oil with an herbal fomentation-Kumburuetaperumkayam Pottani (KAP)-and paste-Sandivadam Lepaya (SVL)-were selected. External applications will be tested against the diclofenac sodium gel and hot water fomentation. KOA patients will be allocated randomly into two arms, and the medications will be given orally for 60 days and externally for 30 days. The primary endpoint is the change in the score on the WOMAC after 08 weeks. WOMAC and KOOS will be recorded and compared between the two arms prior to visiting 1, at the end of 15 days and end of 30 days, and end of the 45 days and end of the second month and 3 months of follow-up. KOOS and WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, and a quality-oflife index are used as secondary outcome measurements. Discussion: This clinical trial will be able to provide evidence-based scientific data on Sri Lankan traditional medicine regimens in the management of KOA. This trial is expected to develop capacity to scientifically evaluate various STM that are claimed to have efficacy in treatment of various disease conditions. Trial registration: ISRCT N5805 0062.
Postgraduate Medical Journal, 2007
Aim: To summarise and critically evaluate the evidence from randomised clinical trials for the effectiveness of individualised herbal medicine in any indication. Methods: Search of electronic databases and approaches to experts in the field to identify randomised, controlled clinical trials of individualised herbal medicine in any indication. Independent data extraction and assessment of methodological quality by two authors and best evidence synthesis. Results: Three randomised clinical trials of individualised herbal medicine were identified. Statistically nonsignificant trends favouring active over placebo treatment in osteoarthritis of the knee probably result from large baseline differences and regression to the mean. Individualised treatment was superior to placebo in four of five outcome measures in the treatment of irritable bowel syndrome, but was inferior to standardised herbal treatment in all outcomes. Individualised herbal treatment was no better than placebo in the prevention of chemotherapy-induced toxicity. Conclusions: There is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication.
Implication of herbal medicines for curing arthritis in Central Western Ghats of Karnataka
Ethnobotany Research and Applications, 2019
Background: The study area lies in the Central Western Ghats which is one of the 36 biodiversity hotspots of the world. Over 4.5 billion people in developing countries and overall 60% of the world population rely on traditional medicine as components of their healthcare. Documentation of such traditional medicinal knowledge is important for conservation of medicinal plants and as well as future beneficiaries. Methods: A purposive sampling method was adapted. A self-structured questionnaire was used to collect the feedbacks of patients. The information (plant parts, mode of usage, dosage) were collected through face to face interviews and discussions with the traditional practitioners. The medicinal plants used were collected for herbarium preparation and identified using standard regional and district floras. Results: A total of 15 medicinal plant species belonging to 11 families for treating arthritis were found in this study. The dominant habit was climbing shrub. Leaves were used in higher proportion (63%). The members of Lamiaceae family were dominant. Three important formulations (pellet, decoction, oil) were used to treat different stages of Arthritis. The statistical outcome from the patients' feedback questionnaire is also mentioned in the paper. Conclusions: Herbal preparations should only be prepared as remedy by a practitioner. The people in and around the study area depend on traditional medicine given by practitioner for arthritis. The conservation of such traditional knowledge for treatment can only be accomplished through systematic documentation and scientific research.
Herbal Medicine Today: Clinical and Research Issues
Evidence-Based Complementary and Alternative Medicine, 2007
Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it ranges from traditional and popular medicines of every country to the use of standardized and tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a Traditional Medical System may indicate safety, but not efficacy of treatments, especially in herbal medicine where tradition is almost completely based on remedies containing active principles at very low and ultra low concentrations, or relying on magical-energetic principles. In the age of globalization and of the so-called 'plate world', assessing the 'transferability' of treatments between different cultures is not a relevant goal for clinical research, while are the assessment of efficacy and safety that should be based on the regular patterns of mainstream clinical medicine. The other black box of herbal-based treatments is the lack of definite and complete information about the composition of extracts. Herbal derived remedies need a powerful and deep assessment of their pharmacological qualities and safety that actually can be realized by new biologic technologies like pharmacogenomic, metabolomic and microarray methology. Because of the large and growing use of natural derived substances in all over the world, it is not wise to rely also on the tradition or supposed millenarian beliefs; explanatory and pragmatic studies are useful and should be considered complementary in the acquisition of reliable data both for health caregiver and patients.
Results of an exploratory trial suggested activity trends of Zingiber offi cinale-Tinopsora cordifolia (platform combination)-based formulations in the treatment of Osteoarthritis (OA) Knees. These formulations were "platform combination+Withania somnifera+Tribulus terrestris" (formulation B) and "platform combination+Emblica offi cinale" (formulation C). This paper reports safety of these formulations when used in higher doses (1.5-2 times) along with Sallaki Guggul and Bhallataka Parpati (a Semecarpus anacardium preparation). Materials and Methods: Ninety-two patients with symptomatic OA knees were enrolled in a 6 weeks investigator blind, randomized parallel effi cacy 4-arm multicenter drug trial. The 4 arms were (I) formulation B, 2 t.i.d.; (II) formulation B, 2 q.i.d.; (III) platform combination+Sallaki Guggul; (IV) Bhallataka Parpati+formulation C. A detailed enquiry was carried out for adverse events (AE) and drug toxicity as per a priori check list and volunteered information. Laboratory evaluation included detailed hematology and metabolic parameters. Patients were examined at baseline, fi rst and fourth weeks, and on completion. Standard statistical program (SPSS version 12.5) was used for analysis. Results: None of the patients reported serious AE or withdrew due to any drug-related toxicity. Mild gut-related (mostly epigastric burning) AE was reported. A mild increase in liver enzymes [serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT)] without any other hepatic abnormality was reported in 2 patients (group IV). Other laboratory parameters remained normal. The mean improvement in active pain visual analog scale (1.4, CI 0.5-2.22), WOMAC (functional activity questionnaire) pain score (1.37, CI 0.22-2.5), and urinary C-TAX (cartilage collagen breakdown product) assay was maximum (NS) in group IV. Lower dose group I showed numerically superior improvement compared with higher dose group II. Conclusion: The results suggested that despite higher doses, standardized Ayurvedic formulations demonstrated a good safety profi le. An improved effi cacy and likely chondroprotective effect was shown by group IV intervention. A confi rmatory drug trial with adequate power and sample size was planned based on the learning from this trial.
Bentham Science , 2022
Introduction: This study is an effort to document extensively and systematically the ethnobotanical and ethnomedicinal knowledge in the four districts (Puri, Cuttack, Bhadrak, and Mayurbhanj) of Odisha in Eastern India. It provides new insights into the rich ethnomedicinal knowledge and plants biodiversity in these four districts. Methods: The method of convenience sampling was conducted to get the ethnobotanical and ethnomedicinal knowledge of the healers. Semi-structured interviews were conducted, and the information got was quantified and documented with the aid of various databases. Eleven traditional healers endowed information on their traditional medicinal knowledge. 74 plant species belonging to 44 botanical families are documented and among these 44 botanical families, five (Rutaceae, Malvaceae, Astaraceae, Annonaceae, and Euphorbiaceae) are mostly used by the healers. The healers mainly use leaves and roots in the medicine's preparation. Results: Twenty-five ailments are treated by these traditional healers, which are majorly dominated by dermatological treatments. The pharmacological mining of these 74 plants revealed that a few pharmacological and biological activities of each medicinal plant had been studied. Our study revealed that these four districts of Odisha have a rich biodiversity of medicinal plants. Conclusion: Promoting the plantation of some of these species can enhance the income of the traditional healers of these districts and simultaneously make the exploitation of these plant species sustainable. We also found that the pharmacological and biological activities of many plant species are yet to be explored.