Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Qurs Mafasil: 2 Tablets (500mg each) orally twice daily to be taken with water after meals for 6 weeks
Control Intervention1: Diacerein: One Capsule (50mg each) orally to be taken with
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of any gender aged 40-65 years. 2. Clinical and Radiographic Knee Osteoarthritis as per the following American College of Rheumatology (ACR) criteria: a. Knee Pain b. Osteophytes in Knee X-Ray, and c. At least 1 of the following 3 criteria: Age >50 years Morning Stiffness Crepitus on active knee motion 3. Knee OA of Kellgren-Lawrence grade II-III (Table-1) 4. ESR 5. Body Mass Index (BMI) 6. Ability to provide Written Informed Consent 7. Willing to come for regular follow-up visits for entire duration of the study
Exclusion criteria
Exclusion criteria: 1. Knee OA of Kellgren-Lawrence grade I and IV 2. Secondary OA, RA, Gout or any other type of Arthritis 3. Obesity (BMI: >=30 kg/m2) 4. Diabetes and other Metabolic Disorder 5. Hypertension and other Cardiovascular Disorder (CVD) 6. Tuberculosis and other Respiratory Disorder 7. Epilepsy and other Neurological Disorder 8. Renal Impairment / Hepatic Impairment/ Malignancy 9. Irritable Bowel Syndrome/ Malabsorption Syndrome/ Gastrointestinal Bypass Surgery 10. Any other significant systemic disease requiring prolonged treatment 11. History of Alcohol and Drug Abuse 12. Pregnancy/ Lactation 13. History of recent clinical trial participation ( 14. Arthroscopy or any Knee Surgery in the previous 6 months 15. Intra-articular treatment (e.g. Corticosteroids or hyaluronic acid) or treatment with medicine for OA in the previous 3 months (e.g. Glucosamine Sulphate, Chondroitin Sulphate, Diacerein, Piascledine) 16. Use of NSAIDs within 10 days prior to Study 17. ESR >40 mm/hr and Serum hs-CRP level >10 mg/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in WOMAC Score from baseline to 6 wk 2. Reduction in VAS Knee pain score from baseline to 6 wk 3. Reduction in time consumed to cover the distance in Walk TestTimepoint: At every 2 weeks i.e. at days 14, 28 and 42. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patients global assessment (PGA) of response to therapy 2. Investigators global assessment (IGA) of response to therapy 3. Reduction in Serum hs-CRP (high sensitivity C-Reactive Protein) levels 4. Changes in Pathological Safety Parameters (Haemogram, Urine RE & ME) 4 5. Changes in Biochemical Safety Parameters (LFTs & KFTs)Timepoint: At baseline and the end of treatment | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed