A clinical trial to evaluate the safety and efficacy of NRINF02 (Turmeric/haldi) Glucosamine sulphate and combination of these two in the treatment of painful knee osteoarthritis

INTERVENTION: Intervention1: NRINF02 (curcuma longa linn.): NRINF02 (500mg/bd/42 days) Intervention2: Glucosamine sulphate: 1500mg;42days;bd Intervention3: Glucosamine sulphate and NR INF02: Glucosamine sulphate 750 mg with NR INF02 500 mg PO twice a day for 42 days Control Intervention1: » Placebo (Microcrystalline cellulose): 400mg;bd;42 days Rescue medication : paracetamol(upto 2000mg) CONDITION: Osteoarthritis PRIMARY OUTCOME: Change in the severity of symptoms Patients were assessed on day 0, 21st and 42nd for intensity of OA symptoms by ; a) Visual analog scale (VAS) (0 to 100) ; b) WOMAC scale ; c) Clinician Global Impression of change (CGIC) ; d) Clinical examination by orthopaedician ; ; Safety evaluation: Reported to the investigators in the event of any adverse events which the patient or the investigator may attribute to the test substance treatment during start of treatment and follow up on day 21st and 42nd.‐‐‐‐‐‐Timepoint: 0,21,42 days SECONDARY OUTCOME: Use of rescue medication ; acetaminophen (paracetamol) was permitted as tablets not exceeding 2000 to 4000 mg/day. The number of tablets used were recorded at each clinic visit and total number was calculated under various treatment arms.‐‐‐‐‐‐Timepoint: 21st and 42nd day INCLUSION CRITERIA: » Patients at least 40 years of age and with clinical evidence [Knee pain for at least six months and on majority of days during the preceding months and radiological evidence (tibio‐femoral osteophytes of at least 1mm Kellgren and Lawrence grade 2 or 3] of OA i.e. Grade 2: definite osteophytes, definite narrowing of joint space and Grade 3: moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.