Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

June 8, 2026 updated by: University of Malaya

Observational Study to Evaluate the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

Knee osteoarthritis is a common condition that causes knee pain, stiffness, reduced mobility, and difficulty performing daily activities. Many patients seek non-surgical treatment options to help manage their symptoms and improve their quality of life.

This study aims to evaluate the effectiveness and safety of Mobithron® Xtra, an oral health supplement containing hyaluronic acid, undenatured type II collagen, and Boswellia serrata extract, in adults with primary knee osteoarthritis. Participants will take Mobithron® Xtra once daily for 3 months as part of their routine care.

The study will observe changes in knee pain, stiffness, physical function, treatment satisfaction, and overall perception of improvement using validated patient-reported outcome measures, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Treatment Satisfaction Questionnaire for Medication (TSQM), and Patient Global Impression of Change (PGIC).

This is a prospective, multicentre observational study involving patients receiving treatment in participating general practitioner clinics throughout Malaysia. No experimental procedures will be performed, and participants will continue to receive standard clinical care. Safety will be monitored throughout the study by documenting any adverse events reported by participants.

The findings from this study may provide valuable real-world evidence regarding the role of Mobithron® Xtra in improving symptoms and quality of life among patients with primary knee osteoarthritis.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kwong Weng Loh, MBBS, MS Orth, MRCS
  • Phone Number: +4407833084270
  • Email: melvinloh@um.edu.my

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.

Description

Inclusion Criteria:

  • Adults ≥40 years with primary knee osteoarthritis (OA)
  • Radiographic diagnosis of primary knee OA (Grade 2 or 3 on Kellgren-Lawrence scale)
  • Stable physiotherapy regimen for ≥3 months (if applicable).
  • Baseline VAS score ≥ 5
  • No prior surgical intervention for the affected knee

Exclusion Criteria:

  • Secondary OA (such as post-traumatic and inflammatory arthritis)
  • Grade IV Primary OA
  • Patients on analgesia (e.g., paracetamol, NSAIDs)
  • Patients on Mobithron (P/Advance/Xtra) or glucosamine products
  • Recent intra-articular injections within 6 months
  • Recent/planned knee surgery within 3 months
  • Severe comorbidities or cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mobithron® Xtra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame: From enrolment to the end of treatment at 3 months
The WOMAC is a validated patient-reported outcome measure assessing pain, stiffness, and physical function in individuals with osteoarthritis. The total WOMAC score ranges from 0 to 96 points, with higher scores indicating worse pain, stiffness, and functional impairment (worse outcome) and lower scores indicating better clinical status (better outcome). Effectiveness will be assessed by comparing the change in WOMAC total score from baseline to the end of treatment at 3 months
From enrolment to the end of treatment at 3 months
Effectiveness of Mobithron® Xtra in reducing pain and symptoms of knee OA, as measured by VAS score
Time Frame: From enrolment to the end of treatment at 3 months
The Visual Analog Scale (VAS) for Pain is a patient-reported measure of pain intensity. Participants rate their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome), while lower scores indicate less pain severity (better outcome). Effectiveness will be assessed by comparing the change in VAS pain scores from baseline to the end of treatment at 3 months.
From enrolment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
Time Frame: From enrolment to the end of treatment at 3 months
This section evaluates the effectiveness, side effects, and convenience of the medication taken by the patients, and is evaluated on the likert scale from 1 to 7. A lower score indicates a worse outcome whereas a higher score indicates a better outcome.
From enrolment to the end of treatment at 3 months
Evaluate patients' global impression of change (PGIC)
Time Frame: From enrolment to the end of treatment at 3 months
The Patient Global Impression of Change (PGIC) is a patient-reported measure that assesses participants' perception of overall change in their condition since starting treatment. Participants rate their overall condition using a 7-point ordinal scale: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, or 7. Very much worse. Higher levels of improvement indicate a better outcome, while worsening categories indicate a poorer outcome.
From enrolment to the end of treatment at 3 months
Identify progressive trends in range of motion improvement from baseline to Month 3
Time Frame: From enrolment to the end of treatment at 3 months
Knee range of motion (ROM) will be assessed using a goniometer and recorded in degrees (°). Measurements will be obtained at baseline and at each follow-up visit through Month 3. Effectiveness will be evaluated by assessing the change in ROM over time and identifying progressive trends in knee mobility improvement. Higher ROM values indicate greater joint mobility and a better outcome.
From enrolment to the end of treatment at 3 months
Evaluate the safety profile of Mobithron® Xtra
Time Frame: From enrolment to the end of treatment at 3 months
Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). The events will be escalated to the research team and recorded in the standardised Adverse Drug Reaction form. All data collected will be monitored continuously throughout the study period.
From enrolment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

BREGO Life Sciences Sdn Bhd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025924-15624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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