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

A randomized, single-blind, comparative, clinical study to evaluate theefficacy and safety of curcumin, combination of curcumin and diclofenac in comparison with diclofenac alone in patients with osteoarthritis of the knee

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10074826

Enrollment

210

Registered

2017-11-29

Start date

2011-02-27

Completion date

Unknown

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

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 dai

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: There is no exclusion criteria.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026