Evaluation of efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee

Evaluation of efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee: An open, prospective, randomized three arm study.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000059

Enrollment

210

Registered

2010-10-01

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: null- Painful osteoarthritis of Knee joint

Interventions

Intervention1: Flexi Joint capsules: Each capsule contains glucosamine sulphate 500 mg plus Omega 3 Fatty Acids in the form of EPA 90 mg &amp

DHA 60 mg) Dose: One soft gelatin capsule 3 times in a day orally for 12 weeks Control Intervention1: Maxepa: Each capsule containing EPA 90 mg &amp

DHA 60 mg. Dose: One capsule 3 times in a day orally for 12 weeks. Control Intervention2: Glucosamine: Glucosamine sulphate 500 mg Dose: One tablet 3 times in a day orally for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: - Patients of either sex above 25 years of age - Clinical diagnosis of primary Osteoarthritis (OA) of the knee (tibiofemoral joint) based on clinical and radiographic criteria. i.e. patients at the time of enrollment in this study having mild to moderate unilateral or bilateral knee pain with or without morning stiffness of <30 minutes duration, and radiographic osteophytes with one or more of the following: ? Marginal lipping ? Narrowing of joint space ? Sharpened articular margin ? sclerosis i.e. damaged thickened or eburnated subchondral bone cysts - ARA Functional Class I, II, or III - Clinical symptoms of OA for at least 6 months prior to study entry - Patient ready to give informed consent.

Exclusion criteria

Exclusion criteria: -Patients having overt joint deformity -Traumatic joint pain. -Patients who require surgical intervention -History of Ischemic Heart Disease -Pregnant and lactating females -Those receiving corticosteroid treatment -Patients with H/O gastritis, peptic ulcer, bleeding ulcers. -Patients with known hepatic or renal impairment -Intra-articular injection of corticosteroids, hyaluronic acid or congeners into study joint with 12 months -Implementation of any other medical therapy for arthritis within 1 week prior to enrollment. -Patients with known hypersensitivity to any component of study drug. -Pregnant and lactating females -Patients with H/O drug/alcoholic abuse -Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study

Design outcomes

Primary

Measure	Time frame
- Improvement in the WOMAC 21 (Western Ontario and McMaster Universities) Score (Sum total of subscale scores for Pain, Stiffness and Function deficit)Timepoint: At the end of study period	—

Secondary

Measure	Time frame
- Reduction of concurrent use of rescue analgesic - Global Efficacy Assessment evaluated on a 5-point scale of Excellent, Good, Fair, Poor, & Worse Timepoint: At the end of study period	—

Countries

India

Contacts

Public ContactDr Khokan Debnath

Merck Limited

khokan.debnath@merck.co.in91-22-66609003

Outcome results

None listed

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