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

Phase 4

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

• Registration Number: CTRI/2020/04/024744
• Lead Sponsor: PGIMS Rohtak

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-VAS Scale <br/ ><br>-Oxford knee score <br/ ><br>-Kellgren and Lawrence grading scaleTimepoint: -VAS Scale at 0,4 and 8 weeks <br/ ><br>-Oxford knee score at 0,4,8 weeks <br/ ><br>-Kellgren and Lawrence grading scale at 0 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
KOOS scoringTimepoint: KOOS scoring done at 0, 8 and 12 weeks