Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

Официальное название

Observational Study to Evaluate the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

Обзор

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.

Первичные конечные точки

• Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) [Срок оценки: 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 [Срок оценки: From enrolment to the end of treatment at 3 months]

Вторичные конечные точки (4)

• Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 [Срок оценки: From enrolment to the end of treatment at 3 months]
• Evaluate patients' global impression of change (PGIC) [Срок оценки: From enrolment to the end of treatment at 3 months]
• Identify progressive trends in range of motion improvement from baseline to Month 3 [Срок оценки: From enrolment to the end of treatment at 3 months]
• Evaluate the safety profile of Mobithron® Xtra [Срок оценки: From enrolment to the end of treatment at 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Малайзия · 1 центр

• Faculty of Medicine — Kuala Lumpur

Публикации

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Идентификаторы

NCT: NCT07643662 · 2025924-15624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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