Healthy Japanese SubjectsNCT05683327
The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function
A study testing UltraHA® 75 mg/capsule and UltraHA® 40 mg/capsule in people with Healthy Japanese Subjects, run by Orthomedico Inc. at 2 sites in Japan.
Trial summary
This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Subjects
- What is being tested?
- UltraHA® 75 mg/capsule and UltraHA® 40 mg/capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesJapan
- Study dates
- 6 Jan 2023to 24 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese
- Men or women
- Adults
- Healthy subjects
- Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
- Subjects whose BMI are 23 kg/m^2 or more and less than 30 kg/m^2
- Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray
- Subjects whose WOMAC score is relatively high
Who cannot join
- Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
- Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
- Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate
- Subjects who are currently taking medications (including herbal medicines) and supplements
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- Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol)
- Subjects who are pregnant, lactating, or planning to become pregnant during this trial
- Subjects who suffer from COVID-19
- Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
- Subjects who are judged as ineligible to participate in this study by the physician
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, 176-0002
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-Ku, Tokyo, 141-0022
About this study
Official title: The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study
This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
Read the detailed description
In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.
- Conditions
- Healthy Japanese Subjects
- Being tested
- UltraHA® 75 mg/capsule, UltraHA® 40 mg/capsule, Placebo
- Keywords
- Hyaluronic Acid, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraHA® 75 mg/capsuleDietary supplement
Take 2 capsules per day at any time.
UltraHA® 40 mg/capsuleDietary supplement
Take 2 capsules per day at any time.
PlaceboDietary supplement
Take 2 capsules per day at any time.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid 150 mg | Active comparator | Take 150 mg/day of hyaluronic acid. Receives: Dietary Supplement: UltraHA® 75 mg/capsule |
| Hyaluronic Acid 80 mg | Active comparator | Take 80 mg/day of hyaluronic acid. Receives: Dietary Supplement: UltraHA® 40 mg/capsule |
| Placebo | Placebo comparator | Take 0 mg/day of hyaluronic acid. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores.
Measured: Week 12
Secondary outcomes (2)
Each WOMAC subscale score at Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of each subscale response is evaluated as the WOMAC subscale score.
Measured: Week 12
Subjective symptoms at Week 12
Assess knee pain, stiffness, discomfort, and health using visual analogue scale. There is a 100 mm straight line with the best and worst degree of sensation indicated at both ends, and the current degree of sensation is marked on the line with the best imaginable state being 0 and the worst state being 100.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start6 Jan 2023
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese SubjectsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthomedico Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED
- Responsible party
- Sponsor
- Investigators
- Tsuyoshi Takara, MD, Study chair, Medical Corporation Seishinkai, Takara Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683327
- Sponsor's protocol ID
- 06793-0003-0E
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05683327
- Acronym / sponsor ID
- 06793-0003-0E
- Conditions
- Healthy Japanese Subjects
- Keywords
- Hyaluronic Acid, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Orthomedico Inc.University, hospital or other
- Collaborators
- BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 13 Jan 2023 (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.
This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
Detailed description
In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid 150 mg | Active comparator | Dietary Supplement: UltraHA® 75 mg/capsuleTake 150 mg/day of hyaluronic acid. |
| Hyaluronic Acid 80 mg | Active comparator | Dietary Supplement: UltraHA® 40 mg/capsuleTake 80 mg/day of hyaluronic acid. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake 0 mg/day of hyaluronic acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Japanese
- Men or women
- Adults
- Healthy subjects
- Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
Key exclusion criteria (11 listed)
- Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
- Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
- Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate
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 |
|---|---|---|
| UltraHA® 75 mg/capsuleTake 2 capsules per day at any time. | Dietary supplement | Hyaluronic Acid 150 mg |
| UltraHA® 40 mg/capsuleTake 2 capsules per day at any time. | Dietary supplement | Hyaluronic Acid 80 mg |
| PlaceboTake 2 capsules per day at any time. | Dietary supplement | Placebo |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
Time frame: Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores.
2 secondary outcomes
Each WOMAC subscale score at Week 12
Time frame: Week 12
Subjective symptoms at Week 12
Time frame: Week 12
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 20 Jul 2023.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
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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. This study is not recruiting at the moment.
Tsuyoshi Takara, MD study chair
Medical Corporation Seishinkai, Takara Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraHA® 75 mg/capsule and UltraHA® 40 mg/capsule in people with Healthy Japanese Subjects, run by Orthomedico Inc. at 2 sites in Japan.
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 8 inclusion and 11 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12 (time frame: Week 12). 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 20 Jul 2023.