Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period
8 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Observacional
Inscrição (Estimado)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kwong Weng Loh, MBBS, MS Orth, MRCS
- Número de telefone: +4407833084270
- E-mail: melvinloh@um.edu.my
Locais de estudo
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malásia, 50603
- Faculty of Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Mobithron® Xtra
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- 2025924-15624
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Não
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