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

NCT07643662 | Not Yet Recruiting

• 1 other identifier: 2025924-15624
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

knee osteoarthritis; mobitron

Outcome Measures

Primary Outcomes (2)

• Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

  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

  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 Outcomes (4)

• Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4

  From enrolment to the end of treatment at 3 months

• Evaluate patients' global impression of change (PGIC)

  From enrolment to the end of treatment at 3 months

• Identify progressive trends in range of motion improvement from baseline to Month 3

  From enrolment to the end of treatment at 3 months

• Evaluate the safety profile of Mobithron® Xtra

  From enrolment to the end of treatment at 3 months

Study Arms (1)

Mobithron® Xtra

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• BREGO Life Sciences Sdn Bhd: collaborator

Study Sites (1)

Faculty of Medicine

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (7)

• Morina D , Fernandez-Castillejo S , Valls RM , Pedret A , Taltavull N , Romeu M , Giralt M , Montero M , Bernal G , Faba J , Perez-Merino L , Gonzalez R , Casajuana MC , Rodriguez A , Arola L , Puiggros F , Moller I , Chetrit C , Martinez-Puig D , Sola R . Effectiveness of a low-fat yoghurt supplemented with rooster comb extract on muscle strength in adults with mild knee pain and mechanisms of action on muscle regeneration. Food Funct. 2018 Jun 20;9(6):3244-3253. doi: 10.1039/c8fo00286j.

  PMID: 29888778 BACKGROUND

• Kumar P, Bansal P, Rajnish RK, Sharma S, Dhillon MS, Patel S, Kumar V. Efficacy of undenatured collagen in knee osteoarthritis: review of the literature with limited meta-analysis. Am J Transl Res. 2023 Sep 15;15(9):5545-5555. eCollection 2023.

  PMID: 37854210 BACKGROUND

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 BACKGROUND

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

  PMID: 31908163 BACKGROUND

• Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.

  PMID: 34505846 BACKGROUND

• Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020 Nov 28;396(10264):1711-1712. doi: 10.1016/S0140-6736(20)32230-3. Epub 2020 Nov 4. No abstract available.

  PMID: 33159851 BACKGROUND

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

  PMID: 31034380 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Kwong Weng Loh, MBBS, MS Orth, MRCS

CONTACT

+4407833084270; melvinloh@um.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

MY (1)