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To study the effect of a drug diacerein in combination with another drug aceclofenac in patients with osteoarthritis of knees

To study efficacy and safety of diacerein as an add-on therapy to aceclofenac in patients with osteoarthritis of knee

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024744
Enrollment
90
Registered
2020-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Diacerein 50 mg OD orally: Dicerein 50 mg OD orally is added to aceclofenac 100 mg BD orally as an add on therapy in patients of knee osteoarthritis in half of the patients Control Inte

Sponsors

PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 40 years of age. 2. Patients newly diagnosed as having knee osteoarthritis based on clinical diagnosis. 3. Patients having radiographic evidence of OA with a grade of 2 or 3 on Kellgren and Lawrence grading scale. 4. Patients willing to give a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Radiographic grade IV knee osteoarthritis as per Kellgren and Lawrence classification. 2. Patients who have earlier been treated with any disease modifying drug. 3. Patients who have been taking any intra-articular injections for atleast 3 months before the study. 4. History of accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee. 5. Patients with known hypersensitivity to study drug. 6. History of painful knee condition other than osteoarthritis, gout or post traumatic arthritis. 7. Patients having history of persistent diarrhea or clinically diagnosed peptic ulcer disease. 8. Patients with severe renal insufficency, hepatic disease. 9. Patients having diabetes mellitus. 10. Patients who refused to give informed consent.

Design outcomes

Primary

MeasureTime frame
-VAS Scale -Oxford knee score -Kellgren and Lawrence grading scaleTimepoint: -VAS Scale at 0,4 and 8 weeks -Oxford knee score at 0,4,8 weeks -Kellgren and Lawrence grading scale at 0 and 8 weeks

Secondary

MeasureTime frame
KOOS scoringTimepoint: KOOS scoring done at 0, 8 and 12 weeks

Countries

India

Contacts

Public ContactDr Vivek Sharma

PGIMS

srishtimakkar29@gmail.com7838572491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026