A clinical trial to compare the effects of Unani research drug Qurs-e-Mafasil with allopathic drug Paracetamol in patients with Osteoarthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/12/038829
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ Improvement in clinical sign and symptoms <br/ ><br>â?¢ Radiological evolution assessed by Joint space narrowing <br/ ><br>â?¢ Evaluation of pain by visual analog scale (VAS pain) <br/ ><br>â?¢ Western Ontario MacMaster University Osteoarthritis Index (WOMAC)Timepoint: 8weeks
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessments for safety <br/ ><br>Timepoint: 8weeks