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Completed
NCT07717957
Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis
Conditions: Knee Osteoarthritis
Sex: All
Ages: 50 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 34
Sponsor: BREGO Life Sciences
Location: International Islamic University Malaysia Kuantan Pahang
Summary
Knee osteoarthritis is a common degenerative joint disorder that causes pain, functional limitation, and reduced quality of life. This prospective, randomized, open-label, parallel-group study was conducted to compare the clinical effectiveness and safety of Mobithron®, a multi-component oral formulation containing hyaluronic acid matrix, undenatured type II collagen, and Boswellia serrata extract, with crystalline glucosamine sulphate in patients with primary knee osteoarthritis. Participants received either Mobithron® or crystalline glucosamine sulphate for three months in addition to a standardized rehabilitation programme. Clinical outcomes were assessed at baseline, Week 2, Week 4, and Month 3. The primary outcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. Secondary outcomes included pain severity measured using the Visual Analogue Scale (VAS) and safety assessment through adverse event monitoring.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 50 to 75 years.
* Diagnosis of primary knee osteoarthritis.
* Radiographic Kellgren-Lawrence grade II, III, or IV knee osteoarthritis.
* No previous surgical intervention to the affected knee.
* At least 6 months since the last intra-articular injection to the affected knee.
* Able and willing to comply with the rehabilitation programme and follow-up -schedule.
* Provided written informed consent.
Exclusion Criteria:
* History of infection involving the affected knee.
* Secondary osteoarthritis (e.g., inflammatory arthritis).
* Unable to comply with the rehabilitation programme or follow-up schedule.
* Declined or unable to provide informed consent.
* Women of child-bearing potential.
* History of severe allergic reactions, including anaphylaxis.
* Severe knee pain at screening (VAS ≥7).
* Minimal or no knee pain at screening (VAS ≤3).
Source: ClinicalTrials.gov (NCT07717957). StuddyBuddy aggregates publicly available trial information.