Long-Term Effects of Mobithron Advance on Knee Osteoarthritis Aims to Investigate the Effects of Mobithron Advance on OA Progression

Официальное название

Long-Term Effects of Mobithron Advance on Knee Osteoarthritis

Обзор

The goal of this clinical trial is to learn if the Mobithron Advance drug works to treat and slow the progression of osteoarthritis (OA) in patients. It will also learn about the safety and long-term effects of this drug. The main questions it aims to answer are: * Does long-term administration of Mobithron Advance can modify the progression of knee osteoarthritis with Kellgren-Lawrence grade 1 to 3 in HUSM patients? * Does long term usage of Mobithron Advance has safety profile? Researchers will compare the Mobithron Advance drug to a placebo (a look-alike substance that contains no drug) to see if said drug works to treat OA. Participants will: * Undergo pre-study assessment (baseline assessments) during first visit * Take oral Mobithron Advance daily for 1 year * Visit the clinic once at 3 months, 6 months and 12 months intervals from the initial visit for follow up assessments

Подробное описание

The study will be conducted as a prospective single-arm trial with a one-year follow-up at the Orthopaedic Clinic, Hospital Universiti Sains Malaysia (HUSM), Malaysia. Participants will include adults over 50 years old diagnosed with primary knee osteoarthritis (OA) of Kellgren-Lawrence grade 1 to 3, based on clinical and radiological criteria. A total of 84 patients will be recruited, accounting for a 10% dropout rate, and will receive daily oral Mobithron Advance for 12 months. Pain will be assessed monthly using the Visual Analogue Scale (VAS) and physical function will be evaluated with the WOMAC index at follow-up visits. Cartilage preservation will be measured through MRI scans at baseline, six months, and twelve months, using a cartilage-specific 3D WATSc sequence to monitor central femoral condyle thickness. Safety and tolerability will be assessed by monitoring renal function, including creatinine and eGFR, alongside recording any adverse events. Data will include demographics, clinical outcomes, and radiological findings, and will be analysed using descriptive statistics, paired t-tests or Wilcoxon signed-rank tests, and linear mixed-effects models to evaluate changes over time.

Вмешательства

• Препарат Type 2 collagen
  This study's intervention is undenatured type II collagen (UC-II) oral tablets, one daily for 12 months, targeting knee osteoarthritis (KL grade 1-3). It differs from other interventions such as glucosamine, chondroitin, hyaluronic acid, or NSAIDs by working through an oral tolerance mechanism with the potential to preserve cartilage and modify disease progression, rather than providing only short-term symptom relief.

Первичные конечные точки

• to assess the thickness of cartilage in osteoarthritic knee included in the study at 3 stages. pre treatment, mid treatment and post treatment. [Срок оценки: 1 year]

Вторичные конечные точки (1)

• assessment of pain score in knee osteoarthritic patient [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Males and female patients above 50 years old at the time of recruitment.
• OA Diagnosis: Patients with one or both knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR).
• OA Grade: Kellgren Lawrence grade 1-3

Критерии исключения

• Secondary arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
• History of joint surgery.
• Patients who received steroid injection treatment within the last 3 months or hyaluronic acid injection treatment within the last 6 months.
• Contraindications to Mobithron Advance (e.g., known allergies, severe liver or kidney disease).
• Patients planning for knee surgery within the research period.
• Patients on pharmacological treatment for osteoarthritis, other than rescue analgesic agent, e.g: glucosamine, chondroitin, oral steroid

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Univerisiti Sains Malaysia (HUSM) — Kota Bharu

Публикации

• Lugo JP, Saiyed ZM, Lau FC, Molina JP, Pakdaman MN, Shamie AN, Udani JK. Undenatured type II collagen (UC-II(R)) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers. J Int Soc Sports Nutr. 2013 Oct 24;10(1):48. doi: 10.1186/1550-2783-10-48. PMID 24153020
• Kalman DS, Heimer M, Valdeon A, Schwartz H, Sheldon E. Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint) on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial. Nutr J. 2008 Jan 21;7:3. doi: 10.1186/1475-2891-7-3. PMID 18208600
• Crowley DC, Lau FC, Sharma P, Evans M, Guthrie N, Bagchi M, Bagchi D, Dey DK, Raychaudhuri SP. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci. 2009 Oct 9;6(6):312-21. doi: 10.7150/ijms.6.312. PMID 19847319

Идентификаторы

NCT: NCT07323745 · mobithron grant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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