Long-Term Effects of Mobithron Advance on Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- to assess the thickness of cartilage in osteoarthritic knee included in the study at 3 stages. pre treatment, mid treatment and post treatment.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mobithron Advance Arm
Treatment Arm will receive one Mobithron Advance oral tablet daily for 12 months. Outcomes will be assessed include cartilage preservation (MRI), pain (VAS), function (WOMAC), and safety (renal function and adverse events)
干预措施: Type 2 collagen (Drug)
结局指标
主要结局
to assess the thickness of cartilage in osteoarthritic knee included in the study at 3 stages. pre treatment, mid treatment and post treatment.
时间窗: 1 year
in term of cartilage assessment, MAGNETIC RESONANCE IMAGING (MRI) PROTOCOL is going to be used; in which, Multiplanar reconstruction (MPR) of the 3D WATSc image will be done to determine the location of central medial femoral condyle cartilage, where thickness of the central medial femoral condyle (cMF) cartilage will be measured on sagittal plane at the most central weight bearing surface. with the above outcome measure, the study can look into Mobithron able to preserve and regenerate cartilages in patients, slowing and reversing cartilage losses as well as disease progression.
次要结局
- assessment of pain score in knee osteoarthritic patient(1 year)
研究者
Amran Ahmed Shokri
Professor
Universiti Sains Malaysia