Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 1, 2024
Open Peer Review Period: Mar 1, 2024 - Apr 26, 2024
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Effectiveness of composite Ayurveda regimen in a black box design for the management of Rheumatoid arthritis: Protocol of community-based study
ABSTRACT
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. Clinical Trial: The study is registered with the Clinical Trial Registry of India (CTRI/2023/06/054203) on 20th June 2023.
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