Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female aged 18 60 years diagnosed with Rheumatoid Arthritis according to the clinician s diagnosis. 2.Patients with mild to moderate disease activity as assessed by Disease Activity Score-28 (DAS28). 3.Patients willing to participate in integrative therapy including Ayurveda and Naturopathy interventions and able to comply with study procedures. 4.Patients who provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with other autoimmune or inflammatory joint diseases such as systemic lupus erythematosus, psoriatic arthritis. 2.Patients with severe comorbid conditions such as uncontrolled hypertension, cardiovascular disease, renal failure, hepatic disease, or active infection. 3.Pregnant or lactating women. 4.Patients who have undergone recent surgery, trauma, or intensive physiotherapy programs within the past 3 months. 5.Patients currently participating in another clinical trial or receiving alternative therapies that may interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain severity assessed using the Visual Analog Scale (VAS)and change in disease activity assessed using the Disease Activity Score 28 (DAS-28).Timepoint: VAS Pain Score: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). DAS-28 Score: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in quality of life assessed using the WHOQOL-BREF questionnaire. 2.Change in inflammatory markers including C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). 3.Change in Rheumatoid Factor (RF) levels. 4.Change in Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibody levels (where assessed). 5.Assessment of medication requirement and dosage adjustments during the study period. 6.Evaluation of therapeutic response to integrated Ayurvedic, Naturopathy, and Yogic interventions as adjunctive management for Rheumatoid Arthritis.Timepoint: 1.WHOQOL-BREF: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). 2.CRP: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). 3.ESR: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). 4.Rheumatoid Factor (RF): Baseline (Week 0) and Endline (Week 12). 5.Anti-CCP Antibody (Optional): Baseline (Week 0) and Endline (Week 12). 6.Medication requirement and dosage adjustments: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). Therapeutic response to the integrative intervention: Baseline (Week 0), Residential Phase (Weeks 1 3 / Discharge), Follow-up (Week 6), Follow-up (Week 9), and Endline (Week 12). | — |
Countries
India
Contacts
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar-249405