Search citation statements
Paper Sections
Citation Types
Year Published
Publication Types
Relationship
Authors
Journals
BACKGROUND Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. The etiology of RA is unknown, and healthcare systems bear a considerable burden due to its increasing prevalence. Ayurveda has taken the foremost place in managing the corresponding disease “Amavata” through a variety of interventions. The study is aimed to generate leads regarding the effectiveness of composite Ayurveda regimens in the management of RA. OBJECTIVE The clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA. METHODS The study will be an Open-label, Community-based interventional study with a black box design comprising a sample size of 200 participants of age between 18 and 65 years, diagnosed as per ACR Criteria (2010). Treatment will be classified based on major disease presentation patterns and customized based on the presence of associated symptoms. The outcome measures include change in Disease Activity Score (DAS)-28 with ESR and disease-specific biochemical & inflammatory markers, change in the participant's assessment of pain, Disability Index score, frequency of use of conventional analgesic/NSAIDs(Non-steroidal anti-inflammatory drugs). Tolerability will also be assessed through occurrence of adverse events. RESULTS The execution of the study has been initiated in April 2023 with the IEC approval followed by CTRI registration on 20th June 2023. The recruitment of participants has been initiated, as of 7th January 2024, 240 participants have been enrolled and 237 are continuing while 3 participants have dropped out due to incompliance. CONCLUSIONS The present study will help to assess the effectiveness of composite Ayurveda interventions in various patterns of disease presentation and their tolerability in RA. CLINICALTRIAL The study is registered with the Clinical Trial Registry of India (CTRI/2023/06/054203) on 20th June 2023.
BACKGROUND Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. The etiology of RA is unknown, and healthcare systems bear a considerable burden due to its increasing prevalence. Ayurveda has taken the foremost place in managing the corresponding disease “Amavata” through a variety of interventions. The study is aimed to generate leads regarding the effectiveness of composite Ayurveda regimens in the management of RA. OBJECTIVE The clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA. METHODS The study will be an Open-label, Community-based interventional study with a black box design comprising a sample size of 200 participants of age between 18 and 65 years, diagnosed as per ACR Criteria (2010). Treatment will be classified based on major disease presentation patterns and customized based on the presence of associated symptoms. The outcome measures include change in Disease Activity Score (DAS)-28 with ESR and disease-specific biochemical & inflammatory markers, change in the participant's assessment of pain, Disability Index score, frequency of use of conventional analgesic/NSAIDs(Non-steroidal anti-inflammatory drugs). Tolerability will also be assessed through occurrence of adverse events. RESULTS The execution of the study has been initiated in April 2023 with the IEC approval followed by CTRI registration on 20th June 2023. The recruitment of participants has been initiated, as of 7th January 2024, 240 participants have been enrolled and 237 are continuing while 3 participants have dropped out due to incompliance. CONCLUSIONS The present study will help to assess the effectiveness of composite Ayurveda interventions in various patterns of disease presentation and their tolerability in RA. CLINICALTRIAL The study is registered with the Clinical Trial Registry of India (CTRI/2023/06/054203) on 20th June 2023.
Background: Despite significant advances in the diagnosis and treatment of rheumatoid arthritis (RA), the clinical outcomes remain unsatisfactory in a significant proportion of patients. Ayurveda management for RA (Amavata) has shown promising clinical outcomes in routine clinical practice and as per published research studies. Objective: The study was designed to assess the therapeutic effect and safety of Ayurveda interventions, Vatari Guggulu (VG), Hingvashtaka Churna (HC), and Brihat Saindhavadya Taila (BS) in the management of RA. Materials and Methods: An open-label, prospective, single-arm multicenter study was conducted at Ayurveda Research Institutes in Patna, Bhubaneswar, and Guwahati with a sample size of 180 participants. Patients of any gender aged 20–60 years with clinically diagnosed RA as per the revised American College of Rheumatology criteria and willing to provide written informed consent to participate in the study were included in the study. Ayurveda interventions, VG, HC, and BS, were administered to the study participants for 12 weeks, with a follow-up at four weeks without intervention. The primary outcome measure was a change in the Disease Activity Score-28 (DAS28) from baseline. The other outcome measures included change in the Indian Health Assessment Questionnaire Disability Index score (HAQ-DI), changes in the acute phase reactants (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]), and change in the quality of life parameters (assessed through the SF-36 questionnaire). Results: A total of 180 participants were enrolled in the study, and data of 179 participants were considered for the final analysis. A statistically significant difference was observed in the outcome parameters, such as a mean change in the DAS28 score, HAQ-DI score, SF-36 score, and ESR and CRP levels (P < 0.001) after 12 weeks of treatment. The mean DAS28 score changed from 6.50 ± 0.790 at baseline to 4.21 ± 1.286 on week 16 follow-up (P < 0.001). No participant withdrew from the study due to adverse events. The trial interventions were well-tolerated and safe. Conclusion: The study outcomes provide preliminary evidence of the safety and potential benefits of the Ayurveda interventions in the management of RA. Further, randomized controlled studies may be planned to generate robust evidence on the therapeutic potential of these interventions so that they can be recommended for use in routine clinical practice. Trial registration: CTRI/2014/12/005242.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.