A clinical trial to study the effects of two drugs, fixed dose combination capsules of Celecoxib and Diacerein and fixed dose combination tablets of Aceclofenac and Diacerein in patients with osteoarthritis of knee and/or hip joints.

A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Fixed dose combination capsules of Celecoxib and Diacerein in comparison with Fixed dose combination tablets of Aceclofenac and Diacerein in patients suffering from osteoarthritis of knee and/or hip joints

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000053

Enrollment

200

Registered

2010-02-22

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: M169- Osteoarthritis of hip, unspecified Health Condition 2: null- Osteoarthritis of knee and/or hip joints Health Condition 3: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Fixed dose combination capsule of Celecoxib 100 mg and Diacerein 50 mg: Twice in a day for 4 weeks Control Intervention1: Fixed dose combination tablet of Aceclofenac 100 mg and Diacere

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex of 18 to 60 years of age. 2. Patients with an established diagnosis of osteoarthritis of knee and/or hip joints with at least moderate pain [at least 5 on the Visual Analogue Scale of 0 to 10 in Short Arthritis Assessment Scale (0 being no pain and 10 being severe pain)] at the affected site at the time of enrollment into the study. 3. Informed consent of the patient/relative/legal representative.

Exclusion criteria

Exclusion criteria: 1. Pregnancy & lactation. 2. Patients with hypersensitivity to Celecoxib, Aceclofenac, any other NSAIDs, Diacerein, anthraquinone derivatives or sulfonamides. 3. Patients with hepatic and / or renal insufficiency. 4. Patients with active peptic ulceration within the last 6 months. 5. Patients suffering from coronary heart disease or any other significant cardiovascular disorder. 6. Patients suffering from any hemorrhagic diasthesis. 7. Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs. 8. Patients with any other serious concurrent illness or malignancy. 9. Patients with continuing history of alcohol and / or drug abuse. 10. Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

Measure	Time frame
The degree of improvement in the Pain aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0).Timepoint: 1,2,3 & 4 weeks	—

Secondary

Measure	Time frame
(1)The degree of improvement in the Physical function of SAS questionnaire on a Visual Analogue Scale (2)The degree of improvement in the Overall well-being aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0). (3)The investigators? global assessment of efficacy at the end of the studyTimepoint: 1,2,3 & 4 weeks	—

Measure

Time frame

(1)The degree of improvement in the Physical function of SAS questionnaire on a Visual Analogue Scale (2)The degree of improvement in the Overall well-being aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0). (3)The investigators? global assessment of efficacy at the end of the studyTimepoint: 1,2,3 & 4 weeks

—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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