Authors
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BREGO Life Sciences -More
Category
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Primary study
Registry of Trials»clinicaltrials.gov
Year
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2026
Knee osteoarthritis is one of the most common degenerative musculoskeletal disorders andis a major cause of chronic pain, reduced physical function, and impaired quality of lifeamong older adults. Conservative treatment remains the cornerstone of management forpatients with early to moderate disease and includes exercise therapy, physiotherapy,weight management, analgesics, and oral nutraceutical supplements. Although crystallineglucosamine sulphate is widely prescribed for symptomatic knee osteoarthritis, publishedevidence regarding its clinical effectiveness remains inconsistent.Mobithron® is a multi‐component oral formulation containing oral hyaluronic acid matrix(Mobilee®), undenatured type II collagen, and Boswellia serrata extract (ApresFlex™).These ingredients have individually demonstrated potential benefits in osteoarthritisthrough complementary mechanisms, including enhancement of joint lubrication, stimulationof endogenous hyaluronic acid synthesis, immunomodulatory effects that may supportcartilage integrity, and inhibition of inflammatory pathways. However, evidenceevaluating the combined formulation in comparison with established oral supplements islimited.This study was designed to compare the clinical effectiveness and safety of Mobithron®with crystalline glucosamine sulphate in patients with primary knee osteoarthritis.This was a single‐centre, prospective, randomized, open‐label, parallel‐group clinicalstudy conducted at the Sultan Ahmad Shah Medical Centre, International Islamic UniversityMalaysia. Eligible patients aged 50 to 75 years with Kellgren‐Lawrence grade II‐IVprimary knee osteoarthritis were randomized in a 1:1 ratio to receive either Mobithron®once daily or crystalline glucosamine sulphate 1500 mg once daily for three months.Medication allocation was performed by an independent pharmacist using a predeterminedallocation schedule, while clinicians and outcome assessors remained blinded to treatmentallocation. All participants underwent the same standardized rehabilitation programmeconsisting of supervised physiotherapy and prescribed home‐based exercises throughout thestudy period.Clinical assessments were performed at baseline, Week 2, Week 4, and Month 3. The primaryoutcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total score from baseline. Secondary outcomes included changes in WOMAC pain,stiffness, and physical function subscales, Visual Analogue Scale (VAS) pain scores atrest and during movement, treatment compliance, analgesic consumption, and safety,including adverse event monitoring throughout the study.The study was conducted in accordance with the Declaration of Helsinki and Good ClinicalPractice principles. Ethical approval was obtained from the IIUM Research EthicsCommittee (IREC), Sultan Ahmad Shah Medical Centre @ International Islamic UniversityMalaysia (Approval ID: IREC 2024‐229; Reference No.: IIUM/504/14/11/2/IREC 2024‐229), andwritten informed consent was obtained from all participants before enrolment.
Epistemonikos ID: 05c0b0df0bf64e36a87a81d312ee3b679c75b862
First added on: Jul 22, 2026