Clinical study to evaluate the efficacy and safety of curcumin, combination of curcumin and diclofenac in comparison with diclofenac alone in patients with osteoarthritis of the knee

INTERVENTION: Participants are randomized into three groups – Group A, Group B and Group C by using a computer generated randomization sheet. Group A: Participants receive Curcumin 500 mg thrice daily (taken orally) for 28 days. Group B: Participants receive Curcumin 500 mg plus diclofenac 50 mg twice daily (taken orally) for 28 days Group C: Participant receive Diclofenac 50 mg twice daily (taken orally)for 28 days. At the time of enrollment, study & rescue medications were dispensed to the enrolled patients as per randomization. Patients are told to keep the record as per instructions and were told to come for two follow up visits (at the end of 2nd week and at the end of 4th week). CONDITION: Osteoarthritis ; Musculoskeletal Diseases ; Osteoarthritis PRIMARY OUTCOME: 1. Efficacy of curcumin in comparison with diclofenac in the management of osteoarthritis of the knee is measured using Visual analogue scale and KOOS (Knee injury and Osteoarthritis Outcome Score) at day 14 and day 28; 2. Efficacy of combination of curcumin & diclofenac in comparison with diclofenac alone in the management of osteoarthritis of the knee is measured usingVisual analogue scale and KOOS (Knee injury and Osteoarthritis Outcome Score) at day 14 and day 28 SECONDARY OUTCOME: 1. Anti‐ulcer effect of curcumin is measured by counting number of H2 blockers consumed by Curcumin and Diclofenac group at day 28; 2. Effect of curcumin on protection against diclofenac induced GI side effects is measured by comparing GI Side effects between Group B received Curcumin 500 mg Capsule plus diclofenac 50 mg Tab andGroup C received Diclofenac 50 mg Tab at Day 28; 3. Antiflatulent effect of curcumin by measuringchange in number of episodes of flatulence from baseline at day 14; 4. Safety of curcumin/diclofenac by measuringside effects at day 14 and day 28; 5. Safety of combination of curcumin and diclofenac by measuring side effects at day 14 and day 28 INCLUSION CRITERIA: 1. Subjects of both sexes between 38 and 65 years of age 2. OA in at least one knee joint (ACR classification for knee OA) confirmed by X ray 3. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment 4. Duration – minimum 3 months to 2 years with no joint deformities 5. Patient ambulant and requiring treatment with anti‐ inflammatory drugs 6. Patient willing to give washout period of 3‐7 days 7. Patient willing to give written informed consent and willing to comply with the trial protocol 8. Patients with knee osteoarthritis.