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A clinical trial to compare the effects of Unani research drug Qurs-e-Mafasil with allopathic drug Paracetamol in patients with Osteoarthritis

A Single Blind, Randomized, parallel group study to compare efficacy and safety of Unani formulation Qurs-e- Mafasil with Paracetamol in patients with Tahajjur al-Mafasil(Osteoarthritis)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038829
Enrollment
60
Registered
2021-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Qurs-e- Mafasil: Two tablets (500 mg each) twice a day orally to be taken with water after meals for 8 weeks Control Intervention1: Tablet Paracetamol: One tablet (500 mg)twice a day or

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects fulfilling ACR clinical criteria for knee OA; andor 2. Subjects having grade II and III Osteoarthritisin knee radiography as perKellegrenLawrence criteria 3. Subjects presenting with/ without the following signs and symptoms: Joint Pain Early morning stiffness Tenderness Swelling Reduced mobility

Exclusion criteria

Exclusion criteria: 1. Subjects having Rheumatoid arthritis, Systemic joint disease or any other type of arthritis 2. Obese Subjects having BMI >30 3. Subjects with uncontrolled Hypertension, Diabetes Mellitus, Tuberculosis, Malignancy, Epilepsy and any other disease requiring long-term treatment 4. Known cases of Renal/ hepatic impairment 5. Patient receiving Intra-articular treatment (e.g., Corticosteroid or Hyaluronic acid) or treatment with medicine for O.A. in previous 3 months (e.g., Glucosamine sulphate, Chondroitin sulphate, Diacerine piascledine) 6. Subjects undergone Arthroscopy or any Knee surgery during last 6 months 7. Pregnancy & lactation

Design outcomes

Primary

MeasureTime frame
â?¢ Improvement in clinical sign and symptoms â?¢ Radiological evolution assessed by Joint space narrowing â?¢ Evaluation of pain by visual analog scale (VAS pain) â?¢ Western Ontario MacMaster University Osteoarthritis Index (WOMAC)Timepoint: 8weeks

Secondary

MeasureTime frame
Haematological and biochemical assessments for safety Timepoint: 8weeks

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

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