Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis

Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis: A Prospective, Randomised, Open-label, Parallel-group Study

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Mobithron®; Dietary supplement: Crystalline Glucosamine Sulphate

Detailed Description

Knee osteoarthritis is one of the most common degenerative musculoskeletal disorders and is a major cause of chronic pain, reduced physical function, and impaired quality of life among older adults. Conservative treatment remains the cornerstone of management for patients with early to moderate disease and includes exercise therapy, physiotherapy, weight management, analgesics, and oral nutraceutical supplements. Although crystalline glucosamine sulphate is widely prescribed for symptomatic knee osteoarthritis, published evidence 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 osteoarthritis through complementary mechanisms, including enhancement of joint lubrication, stimulation of endogenous hyaluronic acid synthesis, immunomodulatory effects that may support cartilage integrity, and inhibition of inflammatory pathways. However, evidence evaluating the combined formulation in comparison with established oral supplements is limited.

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 clinical study conducted at the Sultan Ahmad Shah Medical Centre, International Islamic University Malaysia. Eligible patients aged 50 to 75 years with Kellgren-Lawrence grade II-IV primary 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 predetermined allocation schedule, while clinicians and outcome assessors remained blinded to treatment allocation. All participants underwent the same standardized rehabilitation programme consisting of supervised physiotherapy and prescribed home-based exercises throughout the study period.

Clinical assessments were performed 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 from baseline. Secondary outcomes included changes in WOMAC pain, stiffness, and physical function subscales, Visual Analogue Scale (VAS) pain scores at rest 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 Clinical Practice principles. Ethical approval was obtained from the IIUM Research Ethics Committee (IREC), Sultan Ahmad Shah Medical Centre @ International Islamic University Malaysia (Approval ID: IREC 2024-229; Reference No.: IIUM/504/14/11/2/IREC 2024-229), and written informed consent was obtained from all participants before enrolment.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Pahang
    • Kuantan, Pahang, Malaysia, 25200
      • International Islamic University Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobithron®; Participants received Mobithron® orally once daily for 3 months in addition to a standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.	Dietary supplement: Mobithron®; Mobithron® is an oral nutraceutical formulation containing hyaluronic acid matrix (Mobilee® 80 mg, providing 45 mg hyaluronic acid), undenatured type II collagen (10 mg), and Boswellia serrata extract (ApresFlex™ 100 mg). Participants received one oral dose daily for 3 months in addition to a standardized rehabilitation programme.
Active Comparator: Crystalline Glucosamine Sulphate; Participants received crystalline glucosamine sulphate 1500 mg orally once daily for 3 months in addition to the same standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.	Dietary supplement: Crystalline Glucosamine Sulphate; Crystalline glucosamine sulphate 1500 mg was administered orally once daily for 3 months in addition to the same standardized rehabilitation programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score	Change from baseline in functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Likert questionnaire. The instrument contains 24 items across pain, stiffness and physical-function domains. Each item is scored from 0 to 4, producing a total score ranging from 0 to 96. Higher scores indicate greater pain, stiffness and functional impairment; therefore, a reduction from baseline indicates improvement.	Baseline, Week 2, Week 4, and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Scale Pain Score	Change from baseline in pain severity measured using the Visual Analogue Scale. Pain is rated from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity; therefore, a reduction from baseline indicates improvement. Pain was assessed separately at rest and during movement.	Baseline, Week 2, Week 4, and Month 3

Collaborators and Investigators

• Sponsor: BREGO Life Sciences
• Collaborators: International Islamic University Malaysia

Publications and helpful links

General Publications

• Xu R, Wu J, Zheng L, Zhao M. Undenatured type II collagen and its role in improving osteoarthritis. Ageing Res Rev. 2023 Nov;91:102080. doi: 10.1016/j.arr.2023.102080. Epub 2023 Sep 27.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Dietary Supplements; Pain Measurement; Western Ontario and McMaster Universities Osteoarthritis Index; Crystalline Glucosamine Sulfate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MA0525I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data generated and analysed during this study are not publicly available due to confidentiality and institutional restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No