A Controlled Equivalence Trial Comparing SGPF (Ayurvedic/Herbal) to Celecoxib and Glucosamine in Symptomatic OA Knees (NMITLI)

INTERVENTION: Intervention1: SGPF'C'(AYURVEDIC): 2 CAPSULES THRICE DAILY AFTER MEALS,FOR 24 WEEKS Intervention2: SGPF(AYURVEDIC): 2 CAPSULES THRICE DAILY AFTER MEALS, FOR 24 WEEKS Control Intervention1: CELECOXIB & GLUCOSAMINE: (1) Oral Celecoxib‐ 200 mg in 3 divided doses for 24 weeks (2) Glucosamine sulphate:2 gm, in 3 divided doses CONDITION: SYMPTOMATIC OSTEOARTHRITIS KNEES PRIMARY OUTCOME: i) PainVAS (Visual Analog Scale) on walking ; ii) WOMAC (Western Ontario Macmasters's Osteoarthritis Index for Knee‐Indian CRD, Pune version of questionnaire) pain component (5 questions); iii) WOMAC difficulty (17 questions); ‐‐‐‐‐‐Timepoint: Baseline, Week 2, Week 4, Week8, Week 12, Week 16, Week 20 and Week24. SECONDARY OUTCOME: (1)Walk Time/ Speed of walking(seconds); (2) Patient Global assessment of disease (5 grades); (3)Physicianâ??s Global assessment of disease (5 grades); (4) Patientâ??s Global Assessment of Tolerability ; (5) Physicianâ??s Global Assessment of Tolerability ; (6) Physicianâ??s Global assessment of response to Therapy; (7) Patientâ??s Global assessment of response to Therapy (8) Change in Status of knee arthritis as per patientâ??s perception; (9) HAQ (Stanford Health assessment questionnaire, modified CRD Pune version); (10) WHO‐QOL Bref; (11) Ayurvedic variables (including Prakruti)of efficacy & safety ; (11)Cytokines :Reduction in blood levels of IL‐1 , IL‐6, TNF‐α, MMP‐1, 3, 13, HA and Urinay CTX‐II ; (12)Digitised X‐rays ; ‐‐‐‐‐‐Timepoint: ; (1) Clinical variables at Baseline, Week 2, Week 4, Week8, Week 12, Week 16, Week 20 and Week24.; (2) Laboratory and Digitised X‐rays at baseline and week 24 ; (3) Ayurvedic varaibles at all clinical endpoints INCLUSION CRITERIA: 1. Patients of either sex, 40 to 70 years of age. 2. Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees 3 Presence of typical osteophytes on skiagram knee is mandatory 4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment. 5. Patient ambulant and requiring treatment with an anti‐ inflammatory drug and not receiving regular anti â?? inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change. 6. Willing to come for regular follow â?? up visits. 7. Written Informed Consent from the patient.