Efficacy and Safety Evaluation of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT in Improving Knee Joint Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in WOMAC Osteoarthritis Index Total Score
研究概览
简要总结
The goal of this clinical trial is to evaluate whether INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT improves joint health in adults aged 40-60 years with mild symptomatic knee osteoarthritis (defined by WOMAC total score 20-32 and knee pain VAS score 2-4). It will also assess the safety of the test product.
The main questions it aims to answer are:
Does the test product relieve knee pain, stiffness and physical activity difficulty measured by the WOMAC Osteoarthritis Index? Does the test product reduce pain intensity evaluated by the VAS Pain Scale? Can the test product improve 6-minute walking distance, sit-to-stand ability, stair-climbing performance and the range of motion of the hip and knee joints? What adverse reactions or safety issues do participants have when taking the test product? This is a single-arm, self-controlled clinical trial. Researchers will compare the test results of participants before and after taking the product to verify its efficacy in improving joint function.
Participants will:
Take 2 capsules of the test product once daily, 1 hour after meals, for 60 consecutive days Complete subjective efficacy evaluations, scale assessments and joint function tests at D3, D5, D14, D30, D40 and D60 Undergo safety follow-up tests of blood glucose, liver function and renal function at D56 Report joint symptoms and provide satisfaction feedback during the trial period
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers aged 40-60 years with symptoms of mild knee joint dysfunction; total WOMAC scores ranging from 20 to 32 points, and VAS scores within 2-4 points.
- •In good general health, free from hypertension, diabetes mellitus, systemic diseases and other chronic underlying diseases.
- •No documented history of allergy to any ingredients of the test product.
- •Able to strictly follow the requirements and time schedule of the study protocol, and voluntarily sign the informed consent form.
排除标准
- •Subjects aged less than 40 years or more than 60 years.
- •Those suffering from severe primary diseases involving cardiovascular and cerebrovascular systems, liver, kidney, hematopoietic system and other vital organs.
- •Individuals who have received knee joint surgery within one year.
- •Subjects who underwent intra-articular injection within the past 3 months.
- •Those who have taken anti-arthritic medications (including analgesic drugs) within the preceding one month.
- •Patients clinically diagnosed with gout or hyperuricemia.
- •Females who are pregnant, breastfeeding, or planning to conceive within the next two months.
- •Subjects with severe hepatic or renal insufficiency, hemorrhagic diseases, or those taking anticoagulant drugs.
- •Participants currently or within the last one month enrolled in other clinical trials related to the tested joint site.
- •The final decision on subject enrollment shall be made by the investigators.
研究组 & 干预措施
People aged 40-60 with mild knee osteoarthritis
Take INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT, one capsule at a time, twice a day, during or after meals,
干预措施: INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT (Dietary Supplement)
结局指标
主要结局
Change in WOMAC Osteoarthritis Index Total Score
时间窗: From baseline (Day 0) to the end of the 60-day intervention period, subjects completed efficacy evaluations at six predefined time points: Day3, Day 5, Day 14, Day 30, Day 40, and Day 60.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire that measures knee pain, stiffness, and difficulty with daily activities. Scores range from 0 (no symptoms) to 96 (severe symptoms). The primary endpoint is the change in total score from baseline to the end of the study, to assess overall improvement in knee function.
次要结局
- Change in Knee Pain Intensity (VAS Score)(Baseline (day 0), day28 and day 56)
- 6-minute walk test (distance walked in 6 minutes)(Baseline (day 0), day28 and day 56)
- Participant Global Assessment of Knee Symptom Improvement(From baseline (Day 0) to the end of the 60-day intervention period, subjects completed efficacy evaluations at six predefined time points: Day 3, Day 5, Day 14, Day 30, Day 40, and Day 60.)
- Sit-to-stand test(Baseline(day 0), day28 and day 56)
- Stair-climbing test(Baseline (day 0), day 28 and day 56)
- Joint range of motion(Baseline (day 0), day28 and day 56)
- Changes in liver function parameters(Baseline (day 0), Day 56)
- Changes in renal function parameters(Baseline (day 0), Day 56)