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.
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kwong Weng Loh, MBBS, MS Orth, MRCS
- 電話番号：+4407833084270
- メール：melvinloh@um.edu.my
研究場所
-
-
Kuala Lumpur
-
Kuala Lumpur、Kuala Lumpur、マレーシア、50603
- Faculty of Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Mobithron® Xtra
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
時間枠：From enrolment to the end of treatment at 3 months
|
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
時間枠：From enrolment to the end of treatment at 3 months
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
時間枠：From enrolment to the end of treatment at 3 months
|
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.
|
From enrolment to the end of treatment at 3 months
|
|
Evaluate patients' global impression of change (PGIC)
時間枠：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.
|
From enrolment to the end of treatment at 3 months
|
|
Identify progressive trends in range of motion improvement from baseline to Month 3
時間枠：From enrolment to the end of treatment at 3 months
|
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.
|
From enrolment to the end of treatment at 3 months
|
|
Evaluate the safety profile of Mobithron® Xtra
時間枠：From enrolment to the end of treatment at 3 months
|
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.
|
From enrolment to the end of treatment at 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。