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

NCT07717957 | Completed

• 1 other identifier: MA0525I
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Pain Measurement; Crystalline Glucosamine Sulfate; Dietary Supplements; Western Ontario and McMaster Universities Osteoarthritis Index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Visual Analogue Scale Pain Score

  Baseline, Week 2, Week 4, and Month 3

Study Arms (2)

Mobithron®

EXPERIMENTAL

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®

Crystalline Glucosamine Sulphate

ACTIVE COMPARATOR

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

Interventions

Mobithron® DIETARY_SUPPLEMENT

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.

Mobithron®

Crystalline Glucosamine Sulphate DIETARY_SUPPLEMENT

Crystalline glucosamine sulphate 1500 mg was administered orally once daily for 3 months in addition to the same standardized rehabilitation programme.

Crystalline Glucosamine Sulphate

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• BREGO Life Sciences: lead
• International Islamic University Malaysia: collaborator

Study Sites (1)

International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 37774932 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)