Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period
2026年6月8日 更新者：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.
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kwong Weng Loh, MBBS, MS Orth, MRCS
- 电话号码：+4407833084270
- 邮箱：melvinloh@um.edu.my
学习地点
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Kuala Lumpur
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Kuala Lumpur、Kuala Lumpur、马来西亚、50603
- Faculty of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Mobithron® Xtra
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
大体时间：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)
大体时间：From enrolment to the end of treatment at 3 months
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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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.