ArticleEvidence-based complementary and alternative medicine : eCAM2011
A Randomized Controlled Exploratory Evaluation of Standardized Ayurvedic Formulations in Symptomatic Osteoarthritis Knees: A Government of India NMITLI Project.
Article in Evidence-based complementary and alternative medicine : eCAM, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Safety of Symptomatic Slow-Acting Drugs for Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis.Drugs & aging · 2019Pooled it
- Ayurvedic interventions for osteoarthritis: a systematic review and meta-analysis.Rheumatology international · 2015Pooled it
- Quality of reporting of randomised controlled trials of herbal interventions in ASEAN Plus Six Countries: a systematic review.PloS one · 2015Pooled it
- Oral herbal therapies for treating osteoarthritis.The Cochrane database of systematic reviews · 2014Pooled it
- Trial
- Comparable efficacy of standardized Ayurveda formulation and hydroxychloroquine sulfate (HCQS) in the treatment of rheumatoid arthritis (RA): a randomized investigator-blind controlled study.Clinical rheumatology · 2012Trial
- Review
- Evaluation of the combinatorial effect of3 Biotech · 2019Article
- Cost-effectiveness evaluation of glucosamine for osteoarthritis based on simulation of individual patient data obtained from aggregated data in published studies.Aging clinical and experimental research · 2019Article
- Rheumatology in India--quo vadis?Nature reviews. Rheumatology · 2015Review
- Ayurvedic medicine for rheumatoid arthritis.Current rheumatology reports · 2014Review
- Herbal medicine for rheumatic diseases: promises kept?Current rheumatology reports · 2012Review
- Evaluating higher doses of Shunthi - Guduchi formulations for safety in treatment of osteoarthritis knees: A Government of India NMITLI arthritis project.Journal of Ayurveda and integrative medicine · 2012Article
- Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach.Journal of Ayurveda and integrative medicine · 2011Article
- Diet, Ayurveda and interface with biomedicine.Journal of Ayurveda and integrative medicine · 2010Article
- Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.