Knee Pain ChronicNCT07800676
A+HA Premium Oral Hyaluronic Acid Drink Functional Evaluation Trial for Delaying Joint Pain
A study testing A+HA premium oral hyaluronic acid drink in people with Knee Pain Chronic, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- A+HA premium oral hyaluronic acid drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45 to 80 years.
- Knee osteoarthritis classified as Ahlbäck stage I or II, or Kellgren-Lawrence grade <3.
- A Visual Analogue Scale (VAS) pain score ≤3.
- A Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score >2 or a total WOMAC score >12.
Who cannot join
- Pregnant or breastfeeding women.
- Individuals with a history of knee joint trauma or surgery.
- A body mass index (BMI) ≥ 40 kg/m².
- Individuals with a psychiatric disorder.
- Individuals with severe cardiovascular disease, severe cerebrovascular disease, severe rheumatic disease, crystal deposition arthropathy, or cancer.
- Individuals who use a wheelchair and have a Manual Muscle Testing (MMT) grade ≤3 in the lower extremities, or who require a wheelchair due to physical discomfort.
Show all 10Show fewer
- Use of anti-inflammatory analgesics, corticosteroids, or other medications that may affect the study outcomes within one week before the trial.
- Receipt of intra-articular corticosteroid injections, hyaluronic acid injections, platelet-rich plasma (PRP) therapy, or nerve block treatment within one month before the trial.
- Use of medications or consumption of foods that, in the judgment of a physician or dietitian, may affect the outcome measures.
- Any other condition considered by the physician to make the individual unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University
Taipei
YiWen Chien, PhD, +886 2-27361661 #28363, ychien@tmu.edu.tw
About this study
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain.
Read the detailed description
Arthritis is an inflammation of one or more joints that is characterized by pain, stiffness (especially in the early morning or after exercise), swelling, deformation, and/or reduced mobility. Osteoarthritis, also known as degenerative arthritis, is caused by abnormal damage to the cartilage at the ends of bones. Some patients are caused by injury or congenital abnormalities in the proteins that make up cartilage.
Once the cartilage tissue changes from smooth to rough, or into small pieces. Cartilage is gradually destroyed, and the normally smooth surface becomes irregular. Osteoarthritis usually occurs in joints that require weight load, such as the spine, knees, hips and back, and is usually preceded by some pain and Symptoms of stiffness (mostly stiffness first, then pain), but swelling is not necessarily present. However, a small number of them will cause disability, but once the bones become more fragmented, they are more likely to cause fractures. When osteoarthritis is more severe, the bones can overgrow into osteophytes, known as bone spurs. When bone spurs develop, they can be detected with X-rays, usually in the neck or waist near degenerative cartilage. Formation, these phenomena will not produce any changes in appearance.
Osteoarthritis usually does not occur in adults under the age of 40. Most patients are over the age of 60. Symptoms may be so mild that you are unaware of them until detected by X-ray. The incidence is almost higher in women than in men. three times. Degenerative arthritis is increasing among the elderly in Taiwan. It has become a very important health problem and directly affects the quality of life. Pain control can improve the quality of life.
Previous studies have shown that orally administered hyaluronic acid (HA) can bind to toll-like receptor 4 (TLR-4) on intestinal epithelial cells, thereby increasing the secretion of the anti-inflammatory cytokine IL-10 and suppressor of cytokine signaling 3 (SOCS3), while suppressing the expression of the pro-inflammatory cytokine pleiotrophin, ultimately alleviating osteoarthritis. Regarding the regulation of cartilage degradation-related factors, HA can reduce irregularities on the cartilage surface as well as the loss of cartilage tissue and chondrocytes by suppressing the mRNA expression of MMP-3, MMP-9, and MMP-13 in cartilage tissue. In terms of oxidative stress, HA may also alleviate cartilage damage by downregulating inducible nitric oxide synthase (iNOS), thereby reducing nitric oxide (NO) production, and by inhibiting cyclooxygenase-2 (COX-2) and prostaglandin E2 (PGE2) production. To further enhance its efficacy in improving osteoarthritis, hyaluronic acid was combined with glucosamine and chondroitin. Previous studies have demonstrated that these two ingredients can improve connective tissue function and reduce cartilage matrix degradation. Therefore, the aim of this study was to investigate the effects of A+HA premium oral hyaluronic acid drink on improving knee pain.
- Conditions
- Knee Pain Chronic
- Being tested
- Placebo, A+HA premium oral hyaluronic acid drink
- Keywords
- Knee pain, Hyaluronic acid, Chondroitin, Glucosamine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
1 drink daily
A+HA premium oral hyaluronic acid drinkDietary supplement
1 drink daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo use contents without active ingredients Receives: Dietary Supplement: Placebo |
| A+HA premium oral hyaluronic acid drink | Experimental | A+HA premium oral hyaluronic acid drink contains hyaluronic acid, glucosamine hydrochloride, and chondroitin Receives: Dietary Supplement: A+HA premium oral hyaluronic acid drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Points change of pain evaluation scale
Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark. Record the points that the subjects wrote.
Measured: From the start to the end of treatment at 12 weeks
Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, and the total score was 96 points (Minimum: 0 points; Maximum: 96 points). The question content was divided into three parts: Pain (20 points), Stiffness (8 points), and Physical function (68 points). The higher score meant worse knee joint function. Record the points that the subjects got.
Measured: From the start to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Z-Plus Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800676
- Sponsor's protocol ID
- N202606002
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2026
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A+HA Premium Oral Hyaluronic Acid Drink Functional Evaluation Trial for Delaying Joint Pain
- ClinicalTrials.gov ID
- NCT07800676
- Acronym / sponsor ID
- N202606002
- Conditions
- Knee Pain Chronic
- Keywords
- Knee pain, Hyaluronic acid, Chondroitin, Glucosamine hydrochloride
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Z-Plus Biotechnology Co., Ltd.
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Sep 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.
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain.
Detailed description
Arthritis is an inflammation of one or more joints that is characterized by pain, stiffness (especially in the early morning or after exercise), swelling, deformation, and/or reduced mobility. Osteoarthritis, also known as degenerative arthritis, is caused by abnormal damage to the cartilage at the ends of bones. Some patients are caused by injury or congenital abnormalities in the proteins that make up cartilage.
Once the cartilage tissue changes from smooth to rough, or into small pieces. Cartilage is gradually destroyed, and the normally smooth surface becomes irregular. Osteoarthritis usually occurs in joints that require weight load, such as the spine, knees, hips and back, and is usually preceded by some pain and Symptoms of stiffness (mostly stiffness first, then pain), but swelling is not necessarily present. However, a small number of them will cause disability, but once the bones become more fragmented, they are more likely to cause fractures. When osteoarthritis is more severe, the bones can overgrow into osteophytes, known as bone spurs. When bone spurs develop, they can be detected with X-rays, usually in the neck or waist near degenerative cartilage. Formation, these phenomena will not produce any changes in appearance.
Osteoarthritis usually does not occur in adults under the age of 40. Most patients are over the age of 60. Symptoms may be so mild that you are unaware of them until detected by X-ray. The incidence is almost higher in women than in men. three times. Degenerative arthritis is increasing among the elderly in Taiwan. It has become a very important health problem and directly affects the quality of life. Pain control can improve the quality of life.
Previous studies have shown that orally administered hyaluronic acid (HA) can bind to toll-like receptor 4 (TLR-4) on intestinal epithelial cells, thereby increasing the secretion of the anti-inflammatory cytokine IL-10 and suppressor of cytokine signaling 3 (SOCS3), while suppressing the expression of the pro-inflammatory cytokine pleiotrophin, ultimately alleviating osteoarthritis. Regarding the regulation of cartilage degradation-related factors, HA can reduce irregularities on the cartilage surface as well as the loss of cartilage tissue and chondrocytes by suppressing the mRNA expression of MMP-3, MMP-9, and MMP-13 in cartilage tissue. In terms of oxidative stress, HA may also alleviate cartilage damage by downregulating inducible nitric oxide synthase (iNOS), thereby reducing nitric oxide (NO) production, and by inhibiting cyclooxygenase-2 (COX-2) and prostaglandin E2 (PGE2) production. To further enhance its efficacy in improving osteoarthritis, hyaluronic acid was combined with glucosamine and chondroitin. Previous studies have demonstrated that these two ingredients can improve connective tissue function and reduce cartilage matrix degradation. Therefore, the aim of this study was to investigate the effects of A+HA premium oral hyaluronic acid drink on improving knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo use contents without active ingredients |
| A+HA premium oral hyaluronic acid drink | Experimental | Dietary Supplement: A+HA premium oral hyaluronic acid drinkA+HA premium oral hyaluronic acid drink contains hyaluronic acid, glucosamine hydrochloride, and chondroitin |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 45 to 80 years.
- Knee osteoarthritis classified as Ahlbäck stage I or II, or Kellgren-Lawrence grade <3.
- A Visual Analogue Scale (VAS) pain score ≤3.
- A Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score >2 or a total WOMAC score >12.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women.
- Individuals with a history of knee joint trauma or surgery.
- A body mass index (BMI) ≥ 40 kg/m².
- Individuals with a psychiatric disorder.
- Individuals with severe cardiovascular disease, severe cerebrovascular disease, severe rheumatic disease, crystal deposition arthropathy, or cancer.
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 |
|---|---|---|
| Placebo1 drink daily | Dietary supplement | Placebo |
| A+HA premium oral hyaluronic acid drink1 drink daily | Dietary supplement | A+HA premium oral hyaluronic acid drink |
Primary outcome
Points change of pain evaluation scale
Time frame: From the start to the end of treatment at 12 weeks
Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark. Record the points that the subjects wrote.
Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: From the start to the end of treatment at 12 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, and the total score was 96 points (Minimum: 0 points; Maximum: 96 points). The question content was divided into three parts: Pain (20 points), Stiffness (8 points), and Physical function (68 points). The higher score meant worse knee joint function. Record the points that the subjects got.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A+HA premium oral hyaluronic acid drink in people with Knee Pain Chronic, run by Taipei Medical University at 1 site in Taiwan.
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: opening soon, as of the sponsor's last update on 2 Sep 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Points change of pain evaluation scale (time frame: From the start to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2026.