Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
None listed
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA SCIENCES
Eligibility
Inclusion criteria
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
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 35. History of allergic response/hypersensitivity to trial formulation or its ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of treatment adherence through self-reported compliance log. 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
| Measure | Time frame |
|---|---|
| Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) The proportion of participants undergoing remission as per 28 joint Disease Activity Score using CRP (DAS 28 - CRP). Mean change from baseline in RA Biomarkers ACCP titer, ESR, and CRP. Change from baseline in health assessment questionnaire disability index (HAQ-DI). • Change from baseline in the number of tender joints at each visit. Change from baseline in the joint pain on VAS at each visit. • Improvement in the duration of stiffness from the baseline. Change in the need for Rescue Analgesic medication. Timepoint: Day 30 ,60,90 | — |
Countries
India
Contacts
Public ContactKUMARI ARCHANA
Research Ayurveda Institute Patna
Outcome results
None listed