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

A Clinical Study to Evaluate the Safety and Therapeutic Efficacy of Safuf-e-Chobchini in the Management of Waja-al-Mafasil (Rheumatoid Arthritis); A Block Randomised,Open label,Standard Control Study. - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062472
Enrollment
64
Registered
2024-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Safuf-e-Chobchini: The unani formulation Safuf-e-Chobchini is a unani pharmacopeial formulation commonly prescribed for waja-al-mufasil(arthritis).It contains eight herbal drugs namely

Sponsors

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Pain intensity 2. Joint swelling 3. Morning stiffness 4. Fatigue 5. Restricted movement of joints 6. Joint tendernessTimepoint: Day 0,Day 14, Day 28,Day 42

Secondary

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

Countries

India

Contacts

Public ContactAbhar Qureshi

Regional Research Institute of Unani Medicine (RRIUM) , Srinagar

hussainzaffar6@gmail.com7006021996

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026