Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period
8. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kwong Weng Loh, MBBS, MS Orth, MRCS
- Telefonnummer: +4407833084270
- E-post: melvinloh@um.edu.my
Studiesteder
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- Faculty of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Mobithron® Xtra
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Tidsramme: From enrolment to the end of treatment at 3 months
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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
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From enrolment to the end of treatment at 3 months
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Effectiveness of Mobithron® Xtra in reducing pain and symptoms of knee OA, as measured by VAS score
Tidsramme: From enrolment to the end of treatment at 3 months
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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.
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From enrolment to the end of treatment at 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
Tidsramme: From enrolment to the end of treatment at 3 months
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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.
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From enrolment to the end of treatment at 3 months
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Evaluate patients' global impression of change (PGIC)
Tidsramme: 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.
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From enrolment to the end of treatment at 3 months
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Identify progressive trends in range of motion improvement from baseline to Month 3
Tidsramme: From enrolment to the end of treatment at 3 months
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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.
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From enrolment to the end of treatment at 3 months
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Evaluate the safety profile of Mobithron® Xtra
Tidsramme: From enrolment to the end of treatment at 3 months
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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.
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From enrolment to the end of treatment at 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025924-15624
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