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临床试验/NCT07746466
NCT07746466已完成不适用

Efficacy of Bioactive Collagen Peptide Versus Glucosamine and Chondroitin Sulphate in Grade I-III Knee Osteoarthritis: A Randomized Controlled Trial

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6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
入组人数
150
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

Brief Summary

The goal of this clinical trial is to learn whether bioactive collagen peptide works as well as glucosamine and chondroitin sulphate for improving pain, stiffness, physical function, and quality of life in adults with mild to moderate knee osteoarthritis (Kellgren-Lawrence grades I to III).

The main questions it aims to answer are:

Does bioactive collagen peptide improve knee pain, stiffness, and physical function over 12 weeks? Does bioactive collagen peptide improve health-related quality of life? Is bioactive collagen peptide as safe and effective as glucosamine and chondroitin sulphate for treating knee osteoarthritis?

Researchers will compare bioactive collagen peptide with glucosamine and chondroitin sulphate to determine whether one treatment provides greater improvement in symptoms and quality of life.

Participants will:

Be randomly assigned to receive either bioactive collagen peptide once daily or glucosamine and chondroitin sulphate twice daily for 12 weeks.

Attend study visits at the start of the study and again at 6 and 12 weeks. Complete questionnaires about their knee pain, stiffness, physical function, and overall health-related quality of life at each visit.

Be monitored for treatment adherence, use of rescue pain medication, and any side effects throughout the study.

The information from this study may help healthcare providers better understand whether bioactive collagen peptide is an effective and safe non-surgical treatment option for people with symptomatic knee osteoarthritis.

详细描述

Knee osteoarthritis is one of the leading causes of chronic pain, disability, and reduced quality of life among adults. Current non-surgical management focuses primarily on symptom relief through exercise, weight management, physical therapy, and analgesic medications. Although non-steroidal anti-inflammatory drugs (NSAIDs) remain widely used, their long-term use may be limited by gastrointestinal, cardiovascular, and renal adverse effects. As a result, there is increasing interest in nutraceutical therapies that may provide symptomatic relief with a more favorable safety profile.

Glucosamine and chondroitin sulphate are among the most commonly used symptomatic slow-acting agents for osteoarthritis, although published evidence regarding their effectiveness remains inconsistent. Bioactive collagen peptides have emerged as a potential alternative treatment because they may support cartilage metabolism and reduce symptoms associated with osteoarthritis. However, direct comparative evidence between bioactive collagen peptides and glucosamine-chondroitin sulphate remains limited.

This study is a prospective, single-center, open-label, parallel-group randomized controlled trial designed to compare the efficacy and safety of oral bioactive collagen peptide with oral glucosamine and chondroitin sulphate in adults with symptomatic Kellgren-Lawrence grade I to III knee osteoarthritis.

Participants are randomly assigned in a 1:1 ratio to receive either oral bioactive collagen peptide or oral glucosamine and chondroitin sulphate for 12 weeks. Clinical assessments are performed at baseline, 6 weeks, and 12 weeks. The study evaluates changes in knee pain, stiffness, physical function, and health-related quality of life using validated patient-reported outcome measures, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Safety is evaluated throughout the study by monitoring adverse events, medication compliance, and the use of rescue analgesics.

The primary objective is to determine whether bioactive collagen peptide provides clinical improvement comparable to glucosamine and chondroitin sulphate in reducing symptoms and improving function in patients with knee osteoarthritis. Secondary objectives include evaluating changes in health-related quality of life and comparing the safety and tolerability of both treatment strategies.

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
Single (Outcomes Assessor)

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 aged 40 years and older.
  • •Clinical diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
  • •Radiographic Kellgren-Lawrence grade I, II, or III osteoarthritis in at least one knee.
  • •Willing and able to provide written informed consent.
  • •Willing to comply with the study protocol and attend all follow-up visits.

排除标准

  • •Inflammatory arthritis, including rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathy, or polymyalgia rheumatica.
  • •Post-traumatic osteoarthritis.
  • •Patients with hyperuricemia.
  • •Pregnancy or breastfeeding.
  • •Previous use of collagen peptide or glucosamine-chondroitin supplements before enrollment.
  • •Inability or unwillingness to comply with study procedures or complete follow-up.

研究组 & 干预措施

Bioactive Collagen Peptide (Movgen®)

Experimental

Oral bioactive collagen peptide Fish collagen 4000 mg + Curcuma longa extract 250 mg Dose: 8 g once daily Duration: 12 weeks

干预措施: Bioactive Collagen Peptide (Dietary Supplement)

Glucosamine and Chondroitin Sulphate (Gebon Plus®)

Active Comparator

Glucosamine sulphate 400 mg Chondroitin sulphate 300 mg Methylsulfonylmethane 200 mg Hyaluronic acid 100 mg Boswellia serrata extract 40 mg Smilax chinensis extract 30 mg Curcuma longa extract 30 mg Dose: Twice daily Duration: 12 weeks

干预措施: Glucosamine and Chondroitin Sulphate (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: From baseline to 6 weeks and from 6 weeks to 12 weeks (Total 3 months)

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline to 12 weeks. The WOMAC total score ranges from 0 to 96, with lower scores indicating less pain, stiffness, and physical disability and therefore better clinical outcomes. The questionnaire includes three domains: pain, stiffness, and physical function.

Change in Health-Related Quality of Life (EQ-5D-5L)

时间窗: From baseline to 6 weeks and from 6 weeks to 12 weeks (Total 12 weeks/3months)

Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire from baseline to 12 weeks. Outcomes include the EQ-5D-5L Index, which ranges from less than 0 (health states considered worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life, and the EQ Visual Analogue Scale (EQ VAS), which ranges from 0 to 100, where higher scores indicate better perceived overall health.

次要结局

  • Incidence of Adverse Events(Throughout the 12-week treatment period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumaiya Khan

Profession: Orthopaedic Surgeon, Official title: Senior Registrar (Orthopaedics and Trauma), Principal Investigator

Liaquat National Hospital & Medical College

研究点 (1)

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