Knee OsteoarthritisNCT07033312
Therapeutic Effect of Oral Hyaluronic Acid on Knee Osteoarthritis
A study testing oral hyaluronate and injection and hyaluronate injection in people with Knee Osteoarthritis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- oral hyaluronate and injection and hyaluronate injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2023to 17 Feb 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological evidence of osteoarthritis Kellgren-Lawrence grade 1-3.
- Had knee effusion at the suprapatellar recess under ultrasonographic examination.
- Age greater than 60 years old.
- Refractory to conservative treatments (oral analgesics, physical therapy, or previous intra-articular injections).
Who cannot join
- Rheumatological disorders
- Accidental trauma or fractures involving knees in the past three months
- Neuropathic pain involving lower limbs
- Central nervous system disorders including stroke, Parkinsonism, and spinal cord disorders.
- Depression and cognitive problems
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Combined Treatment of Oral Nutritional Supplement Based on Hyaluronic Acid With Hyaluronic Acid Intra-articular Injection on Symptomatic Knee Osteoarthritis
The goal of this clinical trial is to investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on symptomatic knee osteoarthritis. Researchers will compare it to those who receive only hyaluronic acid injection to see if the combined treatment is better.
Participants will receive a total of three months of oral hyaluronate or placebo agents.
- Conditions
- Knee Osteoarthritis
- Being tested
- oral hyaluronate and injection, hyaluronate injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral hyaluronate and injectionDrug
The patient receives oral hyaluronate and hyaluronate injection
hyaluronate injectionDrug
The patient receives hyaluronate injection only
| Study group | Role | What they receive |
|---|---|---|
| oral hyaluronate plus hyaluronate knee injection | Experimental | oral hyaluronate plus hyaluronate knee injection Receives: Drug: oral hyaluronate and injection |
| hyaluronate knee injection | Placebo comparator | hyaluronate knee injection Receives: Drug: hyaluronate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) aim to reveal pain, stiffness and function of the knee, the minimum and maximum values are 0 and 68, and a higher score mean a worse outcome.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
knee strength
knee extension and flexion torque detected by isokinetic machine
Measured: From enrollment to the end of treatment at 12 weeks
Timed up and go test
the time needed for a patient sits on a chair, stands up walks for 3 meters, and then go back down
Measured: From enrollment 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 posted24 Jun 2025
- Study start21 Apr 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033312
- Sponsor's protocol ID
- SF22377A
- Status last verified
- Nov 2026
- First submitted
- 1 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients we recruited are not willing to share their individual data
Publications
Nelson FR, Zvirbulis RA, Zonca B, Li KW, Turner SM, Pasierb M, Wilton P, Martinez-Puig D, Wu W. The effects of an oral preparation containing hyaluronic acid (Oralvisc(R)) on obese knee osteoarthritis patients determined by pain, function, bradykinin, leptin, inflammatory cytokines, and heavy water analyses. Rheumatol Int. 2015 Jan;35(1):43-52. doi: 10.1007/s00296-014-3047-6. Epub 2014 Jun 5.
PubMed 24899570
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Combined Treatment of Oral Nutritional Supplement Based on Hyaluronic Acid With Hyaluronic Acid Intra-articular Injection on Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07033312
- Acronym / sponsor ID
- SF22377A
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 24 Jun 2025 (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 investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on symptomatic knee osteoarthritis. Researchers will compare it to those who receive only hyaluronic acid injection to see if the combined treatment is better.
Participants will receive a total of three months of oral hyaluronate or placebo agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral hyaluronate plus hyaluronate knee injection | Experimental | Drug: oral hyaluronate and injectionoral hyaluronate plus hyaluronate knee injection |
| hyaluronate knee injection | Placebo comparator | Drug: hyaluronate injectionhyaluronate knee injection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radiological evidence of osteoarthritis Kellgren-Lawrence grade 1-3.
- Had knee effusion at the suprapatellar recess under ultrasonographic examination.
- Age greater than 60 years old.
- Refractory to conservative treatments (oral analgesics, physical therapy, or previous intra-articular injections).
Key exclusion criteria (6 listed)
- Rheumatological disorders
- Accidental trauma or fractures involving knees in the past three months
- Neuropathic pain involving lower limbs
- Central nervous system disorders including stroke, Parkinsonism, and spinal cord disorders.
- Depression and cognitive problems
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 |
|---|---|---|
| oral hyaluronate and injectionThe patient receives oral hyaluronate and hyaluronate injection | Drug | oral hyaluronate plus hyaluronate knee injection |
| hyaluronate injectionThe patient receives hyaluronate injection only | Drug | hyaluronate knee injection |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: From enrollment to the end of treatment at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) aim to reveal pain, stiffness and function of the knee, the minimum and maximum values are 0 and 68, and a higher score mean a worse outcome.
2 secondary outcomes
knee strength
Time frame: From enrollment to the end of treatment at 12 weeks
Timed up and go test
Time frame: From enrollment to the end of treatment at 12 weeks
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 4 Nov 2026.
- Results publication: PubMed 24899570Nelson FR, Zvirbulis RA, Zonca B, Li KW, Turner SM, Pasierb M, Wilton P, Martinez-Puig D, Wu W. The effects of an oral preparation containing hyaluronic acid (Oralvisc(R)) on obese knee osteoarthritis patients determined by pain, function, bradykinin, leptin, inflammatory cytokines, and heavy water analyses. Rheumatol Int. 2015 Jan;35(1):43-52. doi: 10.1007/s00296-014-3047-6. Epub 2014 Jun 5.
- Individual participant dataSharing planned: No. The patients we recruited are not willing to share their individual data
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 oral hyaluronate and injection and hyaluronate injection in people with Knee Osteoarthritis, run by Taichung Veterans General Hospital 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 6 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 4 Nov 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?
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?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033312, which also lists 1 linked publication.
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 4 Nov 2026.