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临床试验/NCT07717957
NCT07717957已完成不适用

Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis: A Prospective, Randomised, Open-label, Parallel-group Study

BREGO Life Sciences1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

研究概览

简要总结

Knee osteoarthritis is a common degenerative joint disorder that causes pain, functional limitation, and reduced quality of life. This prospective, randomized, open-label, parallel-group study was conducted to compare the clinical effectiveness and safety of Mobithron®, a multi-component oral formulation containing hyaluronic acid matrix, undenatured type II collagen, and Boswellia serrata extract, with crystalline glucosamine sulphate in patients with primary knee osteoarthritis. Participants received either Mobithron® or crystalline glucosamine sulphate for three months in addition to a standardized rehabilitation programme. Clinical outcomes were assessed at baseline, Week 2, Week 4, and Month 3. The primary outcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. Secondary outcomes included pain severity measured using the Visual Analogue Scale (VAS) and safety assessment through adverse event monitoring.

详细描述

Knee osteoarthritis is one of the most common degenerative musculoskeletal disorders and is a major cause of chronic pain, reduced physical function, and impaired quality of life among older adults. Conservative treatment remains the cornerstone of management for patients with early to moderate disease and includes exercise therapy, physiotherapy, weight management, analgesics, and oral nutraceutical supplements. Although crystalline glucosamine sulphate is widely prescribed for symptomatic knee osteoarthritis, published evidence regarding its clinical effectiveness remains inconsistent.

Mobithron® is a multi-component oral formulation containing oral hyaluronic acid matrix (Mobilee®), undenatured type II collagen, and Boswellia serrata extract (ApresFlex™). These ingredients have individually demonstrated potential benefits in osteoarthritis through complementary mechanisms, including enhancement of joint lubrication, stimulation of endogenous hyaluronic acid synthesis, immunomodulatory effects that may support cartilage integrity, and inhibition of inflammatory pathways. However, evidence evaluating the combined formulation in comparison with established oral supplements is limited.

This study was designed to compare the clinical effectiveness and safety of Mobithron® with crystalline glucosamine sulphate in patients with primary knee osteoarthritis.

This was a single-centre, prospective, randomized, open-label, parallel-group clinical study conducted at the Sultan Ahmad Shah Medical Centre, International Islamic University Malaysia. Eligible patients aged 50 to 75 years with Kellgren-Lawrence grade II-IV primary knee osteoarthritis were randomized in a 1:1 ratio to receive either Mobithron® once daily or crystalline glucosamine sulphate 1500 mg once daily for three months. Medication allocation was performed by an independent pharmacist using a predetermined allocation schedule, while clinicians and outcome assessors remained blinded to treatment allocation. All participants underwent the same standardized rehabilitation programme consisting of supervised physiotherapy and prescribed home-based exercises throughout the study period.

Clinical assessments were performed at baseline, Week 2, Week 4, and Month 3. The primary outcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline. Secondary outcomes included changes in WOMAC pain, stiffness, and physical function subscales, Visual Analogue Scale (VAS) pain scores at rest and during movement, treatment compliance, analgesic consumption, and safety, including adverse event monitoring throughout the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 50 to 75 years.
  • Diagnosis of primary knee osteoarthritis.
  • Radiographic Kellgren-Lawrence grade II, III, or IV knee osteoarthritis.
  • No previous surgical intervention to the affected knee.
  • At least 6 months since the last intra-articular injection to the affected knee.
  • Able and willing to comply with the rehabilitation programme and follow-up -schedule.
  • Provided written informed consent.

排除标准

  • History of infection involving the affected knee.
  • Secondary osteoarthritis (e.g., inflammatory arthritis).
  • Unable to comply with the rehabilitation programme or follow-up schedule.
  • Declined or unable to provide informed consent.
  • Women of child-bearing potential.
  • History of severe allergic reactions, including anaphylaxis.
  • Severe knee pain at screening (VAS ≥7).
  • Minimal or no knee pain at screening (VAS ≤3).

研究组 & 干预措施

Crystalline Glucosamine Sulphate

Active Comparator

Participants received crystalline glucosamine sulphate 1500 mg orally once daily for 3 months in addition to the same standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.

干预措施: Crystalline Glucosamine Sulphate (Dietary Supplement)

Mobithron®

Experimental

Participants received Mobithron® orally once daily for 3 months in addition to a standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.

干预措施: Mobithron® (Dietary Supplement)

结局指标

主要结局

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

时间窗: Baseline, Week 2, Week 4, and Month 3

To evaluate the change in functional status by comparing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline to Month 3 between the Mobithron® and crystalline glucosamine sulphate groups.

Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score

时间窗: Baseline, Week 2, Week 4, and Month 3

Change from baseline in functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Likert questionnaire. The instrument contains 24 items across pain, stiffness and physical-function domains. Each item is scored from 0 to 4, producing a total score ranging from 0 to 96. Higher scores indicate greater pain, stiffness and functional impairment; therefore, a reduction from baseline indicates improvement.

次要结局

  • Change in Visual Analogue Scale (VAS) Pain Score(Baseline, Week 2, Week 4, and Month 3)
  • Change in Visual Analogue Scale Pain Score(Baseline, Week 2, Week 4, and Month 3)

研究者

发起方
BREGO Life Sciences
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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