A clinical trial to study the effects of two drugs, Glucosamine 750 mg +Diacerine 50mg + Aceclofenac 100 mg Tablet in patients with osteoarthritis of knee joints.
Phase 3
Completed
- Registration Number
- CTRI/2010/091/001092
- Lead Sponsor
- M/S Jenburkt Pharmaceuticals Ltd.Nirmala Apartments,93, Jayprakash Road, Andheri (West),Mumbai - 400 058. India.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
All the patients with dully filled Informed Consent Forms ( ICF).
Age : 35 to 40 years.
Sex : Both male and female.
The patients with radiologically defined symptoms of osetoarthritis established diagnosis of osteoarthritis already on analgesic treatment with NSAID ( diclofenac sodium, , Aceclofenac, nimesulide, Naproxen ) not having significant pain relief in terms of pain and disability.
Exclusion Criteria
Patients with advance disease such as :
* Patients with secondary arthritis such as infective, tubercular or psoriatic arthritis.
* Patients who had arthroplasty.
* Patients having undergone arthroscopic washout of knee joint.
* Patients with concomittant diseases such as malignancy, HIV.
* Pregnancy nd lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary parameters:<br>1) Pain relief by Visual Analogue scale of 100 millimeters ( VAS)<br>2. Macgill Questionaire for Pain.<br>3. Clinical examination for joint pain, stiffness,tenderness and swellings.<br>4. The range of movement extension by Long-arm Goniometer.Timepoint: 30 days.
- Secondary Outcome Measures
Name Time Method secondery parameters :<br>1. Quality of Life ( European Q5D)<br>2. Physician's Global Assessment - 1 to 5 ( Very poor, Poor, Fair, Good and excellent.)Timepoint: 30 days.