Efficacy of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT on Bone and Joint Health
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
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国
- Guangzhou Jinyu Health Examination Center
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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,
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Take one pill at a time, twice a day, with meals or after meals
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in WOMAC Osteoarthritis Index Total Score
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Knee Pain Intensity (VAS Score)
時間枠：Baseline (day 0), day28 and day 56
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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.
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Baseline (day 0), day28 and day 56
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6-minute walk test (distance walked in 6 minutes)
時間枠：Baseline (day 0), day28 and day 56
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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
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Participant Global Assessment of Knee Symptom Improvement
時間枠：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.
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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.
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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.
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Sit-to-stand test
時間枠：Baseline(day 0), day28 and day 56
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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：
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
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Stair-climbing test
時間枠：Baseline (day 0), day 28 and day 56
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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
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Joint range of motion
時間枠：Baseline (day 0), day28 and day 56
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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.
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Baseline (day 0), day28 and day 56
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Changes in liver function parameters
時間枠：Baseline (day 0), Day 56
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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
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Baseline (day 0), Day 56
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Changes in renal function parameters
時間枠：Baseline (day 0), Day 56
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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.
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Baseline (day 0), Day 56
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- GZ251212069
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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