Mild Knee Osteoarthritis (WOMAC 20-32, VAS 2-4)NCT07658950
Efficacy of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT on Bone and Joint Health
A study testing INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT in people with Mild Knee Osteoarthritis (WOMAC 20-32, VAS 2-4), run by Hong Kong Junhuo Biotechnology Co., Limited at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Mild Knee Osteoarthritis (WOMAC 20-32, VAS 2-4)
- What is being tested?
- INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Being tested
- INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENTDietary supplement
Take one pill at a time, twice a day, with meals or after meals
| Study group | Role | What they receive |
|---|---|---|
| People aged 40-60 with mild knee osteoarthritis | Experimental | Take INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT, one capsule at a time, twice a day, during or after meals, Receives: Dietary Supplement: INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Osteoarthritis Index Total Score
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.
Measured: 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.
Secondary outcomes (8)
Change in Knee Pain Intensity (VAS Score)
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.
Measured: Baseline (day 0), day28 and day 56
6-minute walk test (distance walked in 6 minutes)
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.
Measured: Baseline (day 0), day28 and day 56
Participant Global Assessment of Knee Symptom Improvement
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.
Measured: 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
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：
- Excellent: All 3 movements are standard with upright trunk, no body sway or knee pain, and no auxiliary support required.
- Good: All 3 movements are basically standard with occasional slight self-adjustable sway, no knee pain, and no auxiliary support required.
- Pass: Slight knee soreness or obvious body sway occurs during movements, or 1-2 movements require knee support by hands to complete.
- 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.
Measured: Baseline(day 0), day28 and day 56
Stair-climbing test
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.
Measured: Baseline (day 0), day 28 and day 56
Joint range of motion
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.
Measured: Baseline (day 0), day28 and day 56
Changes in liver function parameters
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
Measured: Baseline (day 0), Day 56
Changes in renal function parameters
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.
Measured: Baseline (day 0), Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jan 2026
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Knee Osteoarthritis (WOMAC 20-32, VAS 2-4)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Junhuo Biotechnology Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou King Test Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658950
- Sponsor's protocol ID
- GZ251212069
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT in Improving Knee Joint Function
- ClinicalTrials.gov ID
- NCT07658950
- Acronym / sponsor ID
- GZ251212069
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hong Kong Junhuo Biotechnology Co., LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Guangzhou King Test Technology Co., Ltd.
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People aged 40-60 with mild knee osteoarthritis | Experimental | Dietary Supplement: INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENTTake INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT, one capsule at a time, twice a day, during or after meals, |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENTTake one pill at a time, twice a day, with meals or after meals | Dietary supplement | People aged 40-60 with mild knee osteoarthritis |
Primary outcome
Change in WOMAC Osteoarthritis Index Total Score
Time frame: 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.
8 secondary outcomes
Change in Knee Pain Intensity (VAS Score)
Time frame: Baseline (day 0), day28 and day 56
6-minute walk test (distance walked in 6 minutes)
Time frame: Baseline (day 0), day28 and day 56
Participant Global Assessment of Knee Symptom Improvement
Time frame: 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
Time frame: Baseline(day 0), day28 and day 56
Stair-climbing test
Time frame: Baseline (day 0), day 28 and day 56
Joint range of motion
Time frame: Baseline (day 0), day28 and day 56
Changes in liver function parameters
Time frame: Baseline (day 0), Day 56
Changes in renal function parameters
Time frame: Baseline (day 0), Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT in people with Mild Knee Osteoarthritis (WOMAC 20-32, VAS 2-4), run by Hong Kong Junhuo Biotechnology Co., Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC Osteoarthritis Index Total Score (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.