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Efficacy of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT on Bone and Joint Health

2026年6月15日 更新者：Hong Kong Junhuo Biotechnology Co., Limited

Efficacy and Safety Evaluation of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT in Improving Knee Joint Function

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

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

33

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国
        • Guangzhou Jinyu Health Examination Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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,
膳食补充剂：INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT
Take one pill at a time, twice a day, with meals or after meals

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in WOMAC Osteoarthritis Index Total Score
大体时间：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.
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.

次要结果测量

结果测量
措施说明
大体时间
Change in Knee Pain Intensity (VAS Score)
大体时间：Baseline (day 0), day28 and day 56
Knee pain is measured using a 10-point Visual Analog Scale (VAS), where 0 = no pain and 10 = worst possible pain. Participants rate their pain at rest and during daily activities (e.g., walking, climbing stairs). Changes in these scores from baseline are tracked over the intervention period.
Baseline (day 0), day28 and day 56
6-minute walk test (distance walked in 6 minutes)
大体时间：Baseline (day 0), day28 and day 56

The test is conducted in a 20-30 meter flat corridor, with the ambient temperature maintained at 20-25℃ and relative humidity at 40%-60%. Upon instruction, the subject walks continuously for 6 minutes at the maximum tolerable speed. The tester gives a time reminder every minute. If the subject feels significant discomfort, they may rest or terminate the test at any time, and relevant information shall be documented. Once the timing ends, the final position of the subject is recorded, and the total walking distance is calculated.

Reporting method:Change from baseline to Day 28 and Day 56, presented as the mean distance, mean change from baseline, and percentage improvement at each time point.
Baseline (day 0), day28 and day 56
Participant Global Assessment of Knee Symptom Improvement
大体时间：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.
At the end of the study, participants rate their overall knee symptom improvement using a 5-point scale (1 = much worse, 5 = much better). This self-reported measure captures how participants perceive the effect of the intervention on their daily lives.
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
大体时间：Baseline(day 0), day28 and day 56

1.Test Requirements: Subjects complete 3 consecutive stand-sit movements at a uniform speed without external assistance from handrails, walls or other supports.

2.Evaluation Criteria：

  1. Excellent: All 3 movements are standard with upright trunk, no body sway or knee pain, and no auxiliary support required.
  2. Good: All 3 movements are basically standard with occasional slight self-adjustable sway, no knee pain, and no auxiliary support required.
  3. Pass: Slight knee soreness or obvious body sway occurs during movements, or 1-2 movements require knee support by hands to complete.
  4. Fail: Unable to complete movements independently, requiring external assistance; or presenting with collapsing sitting posture and obvious lower limb weakness during standing up.

3.Reporting method: Change in sit-to-stand test score from baseline and percentage improvement at each time point.
Baseline(day 0), day28 and day 56
Stair-climbing test
大体时间：Baseline (day 0), day 28 and day 56

Subjects complete a stair-climbing test on a 30-step staircase (16 cm per step). Performance is scored on a 4-point scale based on knee pain, stability, and functional ability to assess improvements in joint function and mobility.

Reporting method:Change in sit-to-stand test score from baseline to Day 56, presented as the mean change and percentage improvement from baseline.
Baseline (day 0), day 28 and day 56
Joint range of motion
大体时间：Baseline (day 0), day28 and day 56
Test items: hip external rotation, hip internal rotation, knee flexion and extension Reporting method: Change in hip external rotation, hip internal rotation, knee flexion and extension range of motion (degrees) from baseline to test day, presented as the mean change and percentage improvement from baseline.
Baseline (day 0), day28 and day 56
Changes in liver function parameters
大体时间：Baseline (day 0), Day 56
Test items:Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase（GGT） Reporting method: Changes in each parameter at baseline and Day 56, as well as the proportion of subjects with values exceeding the upper limit of normal range
Baseline (day 0), Day 56
Changes in renal function parameters
大体时间：Baseline (day 0), Day 56
Test items: Urea (UREA), Creatinine (Cr), Uric Acid (UA) Reporting method: Changes of each parameter at baseline and Day 56, and the proportion of subjects with values exceeding the upper limit of normal range.
Baseline (day 0), Day 56

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hong Kong Junhuo Biotechnology Co., Limited

合作者

Guangzhou King Test Technology Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月15日

初级完成 (实际的)

2026年3月12日

研究完成 (实际的)

2026年3月12日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • GZ251212069

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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