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

• Conditions: Osteoarthritis of knee joints

• 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

This study is a randomised, open label, multicentric trial to compare the efficacy, tolerability and safety of fixed dose combination of " Glucosamine 750 mg, Diacerine 50mg, Aceclofenac 100 mg Vs Diacerine 50 mg and Aceclofenac 100 mg in patients with Osteoarthritis of knee joint that will be conducted in four centres in India.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-15
• Last Update Posted: 2013-05-02

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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary parameters:1) Pain relief by Visual Analogue scale of 100 millimeters ( VAS)2. Macgill Questionaire for Pain.3. Clinical examination for joint pain, stiffness,tenderness and swellings.4. The range of movement extension by Long-arm Goniometer.	30 days.

Secondary Outcome Measures

Name	Time	Method
secondery parameters :1. Quality of Life ( European Q5D)2. Physician's Global Assessment - 1 to 5 ( Very poor, Poor, Fair, Good and excellent.)	30 days.

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

KEM Hospital, Mumbai, pkirtic@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

RN Cooper Hospital, Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Smt.N.H.L.Muni.Medical College & Hospital,Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv Oza

Principal investigator

Rajivoza59@hotmail.com