To evaluate the safety and effectiveness of Unani formulation namely Safuf-e-Chobchini in patients with Rheumatoid arthritis.

Phase 2

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

Registration Number: CTRI/2024/02/062472

Lead Sponsor: Central Council for Research in Unani Medicine , New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients in the age group of 18 to 65 years.

2.Patients irrespective of gender.

3.Patients who fulfill the criteria of the New American College of Rheumatology European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis.

4. Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily.

Exclusion Criteria

1.Women who are pregnant, planning pregnancy, or breast feeding.

2.Patients with systemic,extra-articular manifestations of rheumatoid arthritis.

3.Patients having gouty arthritis and psoriatic arthritis.

4.Patients with history of systemic disease like uncontrolled diabetes mellitus and hypertension,hepatic dysfunction and impaired renal function.

5.Patients currently receiving or have received intra-articular treatment, oral or parenteral corticosteroids, or NSAIDs within 2 weeks, DMARDs or anticipated IFN therapy within 4 weeks prior to study entry.

6.Obese subjects with BMI =35

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain intensity <br/ ><br>2. Joint swelling <br/ ><br>3. Morning stiffness <br/ ><br>4. Fatigue <br/ ><br>5. Restricted movement of joints <br/ ><br>6. Joint tendernessTimepoint: Day 0,Day 14, Day 28,Day 42

Secondary Outcome Measures

Name	Time	Method
1.DAS 28 <br/ ><br>2.HAQ disability index score <br/ ><br>3.Erythrocyte sedimentation rate (ESR) <br/ ><br>4.Quantitative C -reactive protein (CRP) <br/ ><br>5.Quantitative Rheumatoid factor (RF) <br/ ><br>6.Quantitative Anti-citrullinated protein antibody (ACPA) <br/ ><br>7. Interleukin 6 (IL-6) <br/ ><br>Timepoint: Day 0,Day 43