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.

Multicentric, Open label, Randomized, Parallel-group, Active-controlled Clinical trial of the Fixed Dose Combination of Glucosamine 750 mg , Diacerein 50 mg and Aceclofenac 100 mg In patients with osteoarthritis of knee joint.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001092

Enrollment

200

Registered

2010-09-09

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

None listed

Interventions

Intervention1: Glucosamine 750mg ,Diacerine 50mg ,Aceclofenac 100mg Tab: One Tab two times a dayfor 30 days. Control Intervention1: Diacerine 50mg, Aceclofenac 100 mg Tab: One tab two times a day for

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 30 days.	—

Secondary

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

Countries

India

Contacts

Public ContactDr Nitin M Rathod

nitinmr@yahoo.in

Outcome results