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

Official title

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

Overview

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.

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (4)

• Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 [Time frame: 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]
• 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]
• Evaluate the safety profile of Mobithron® Xtra [Time frame: From enrolment to the end of treatment at 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Malaysia · 1 center

• Faculty of Medicine — Kuala Lumpur

Publications

• 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 ac PMID 29888778
• 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
• 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):1578-1 PMID 31278997
• 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 Founda PMID 31908163
• 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
• 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
• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9. PMID 31034380

Identifiers

NCT: NCT07643662 · 2025924-15624

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗