Management of Rheumatoid Arthritis Through Ayurveda Interventio

Phase 3

Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Registration Number: CTRI/2023/04/051829

Lead Sponsor: CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA SCIENCES

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

2.A diagnosis of RA according to the ACR 2010 Rheumatoid Arthritis Classification Criteria

3.Patients who are not on any conventional medicines such as methotrexate, biological Agents, glucocorticoids, cloroquine, and DMARDs or any other traditiona medicine for RA in the last 3 months prior to the treatment period.

4.Patients willing to give informed consent.

Exclusion Criteria

History or current diagnosis of any other inflammatory arthritis such as psoriatic arthritis or ankylosing spondylitis, still’s disease, septic arthritis, gouty arthritis etc or a non-inflammatory type of arthritis (e.g. osteoarthritis ) or fibromyalgia.

Severity score >5.1 on DAS 28-CRP.

Patient taking participation in any other clinical trial or have participated in any clinical trial in last 3 months.

Any other condition which the P.I.thinks may jeopardize the study.

Uncontrolled HTN. ( >160/100)

Uncontrolled DM (HbA1c >8.0).

Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 3 months, Renal Dysfunction( defined as S. creatinine > 1.2 mg/dl, asthmatic and COPD patients or other concurrent severe disease.

Participants with BMI <18 and >35.

History of allergic response/hypersensitivity to trial formulation or its ingredients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of treatment adherence through self-reported compliance log. <br/ ><br>Assessment of the tolerability of the Ayurveda therapeutic regimen through the reported incidence of adverse events during the study period.Timepoint: Day 30 ,60,90

Secondary Outcome Measures

Name	Time	Method
Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) <br/ ><br>The proportion of participants undergoing remission as per 28 joint Disease Activity Score using CRP (DAS 28 - CRP). <br/ ><br>Mean change from baseline in RA Biomarkers ACCP titer, ESR, and CRP. <br/ ><br>Change from baseline in health assessment questionnaire disability index (HAQ-DI). <br/ ><br>•Change from baseline in the number of tender joints at each visit. <br/ ><br>Change from baseline in the joint pain on VAS at each visit. <br/ ><br>•Improvement in the duration of stiffness from the baseline. <br/ ><br>Change in the need for Rescue Analgesic medication. <br/ ><br>Timepoint: Day 30 ,60,90