Knee OsteoarthritisNCT07717957
Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis
A study testing Mobithron® and Crystalline Glucosamine Sulphate in people with Knee Osteoarthritis, run by BREGO Life Sciences at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mobithron® and Crystalline Glucosamine Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
International Islamic University Malaysia
Kuantan, Pahang, 25200
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mobithron®, Crystalline Glucosamine Sulphate
- Keywords
- Osteoarthritis, Pain Measurement, Crystalline Glucosamine Sulfate, Dietary Supplements, Western Ontario and McMaster Universities Osteoarthritis Index
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Crystalline Glucosamine SulphateDietary supplement
Crystalline glucosamine sulphate 1500 mg was administered orally once daily for 3 months in addition to the same standardized rehabilitation programme.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Crystalline Glucosamine Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, Week 4, and Month 3
Secondary outcomes (1)
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.
Measured: Baseline, Week 2, Week 4, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- BREGO Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Islamic University Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717957
- Sponsor's protocol ID
- MA0525I
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data generated and analysed during this study are not publicly available due to confidentiality and institutional restrictions.
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.
PubMed 37774932
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis: A Prospective, Randomised, Open-label, Parallel-group Study
- ClinicalTrials.gov ID
- NCT07717957
- Acronym / sponsor ID
- MA0525I
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Pain Measurement, Crystalline Glucosamine Sulfate, Dietary Supplements, Western Ontario and McMaster Universities Osteoarthritis Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BREGO Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- International Islamic University Malaysia
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobithron® | Experimental | Dietary Supplement: 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. |
| Crystalline Glucosamine Sulphate | Active comparator | Dietary Supplement: Crystalline Glucosamine SulphateParticipants 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Mobithron® |
| Crystalline Glucosamine SulphateCrystalline glucosamine sulphate 1500 mg was administered orally once daily for 3 months in addition to the same standardized rehabilitation programme. | Dietary supplement | Crystalline Glucosamine Sulphate |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
Time frame: Baseline, Week 2, Week 4, and Month 3
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.
1 secondary outcome
Change in Visual Analogue Scale Pain Score
Time frame: Baseline, Week 2, Week 4, and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 37774932Xu 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.
- Individual participant dataSharing planned: No. The individual participant data generated and analysed during this study are not publicly available due to confidentiality and institutional restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobithron® and Crystalline Glucosamine Sulphate in people with Knee Osteoarthritis, run by BREGO Life Sciences at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score (time frame: Baseline, Week 2, Week 4, and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07717957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.