Observational Study to Evaluate the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mobithron® Xtra
结局指标
主要结局
Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: 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
Effectiveness of Mobithron® Xtra in reducing pain and symptoms of knee OA, as measured by VAS score
时间窗: 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.
次要结局
- Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4(From enrolment to the end of treatment at 3 months)
- Evaluate patients' global impression of change (PGIC)(From enrolment to the end of treatment at 3 months)
- Identify progressive trends in range of motion improvement from baseline to Month 3(From enrolment to the end of treatment at 3 months)
- Evaluate the safety profile of Mobithron® Xtra(From enrolment to the end of treatment at 3 months)