A clinical trial to compare the effects of two drugs Qurs Mafasil and Diacerein in patients with pain in joints

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: 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 water after meals for 6weeks CONDITION: Health Condition 1: M179‐ Osteoarthritis of knee, unspecified PRIMARY OUTCOME: 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 OUTCOME: 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 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 <30 minutes Crepitus on active knee motion 3. Knee OA of Kellgren‐Lawrence grade II‐III (Table‐1) 4. ESR <40 mm/h 5. Body Mass Inde X(BMI) <30 kg/m2 6. Ability to provide Written Informed Consent 7. Willing to come for regular follow‐up visits for entire duration of the study
Epistemonikos ID: 43a01459db9f219c9c5a09d14f3f39cde417b75e
First added on: Feb 20, 2024