Healthy Japanese Subjects
Conditions
Keywords
Hyaluronic Acid, Knee
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTUltraHA® 75 mg/capsule
Take 2 capsules per day at any time.
DIETARY_SUPPLEMENTUltraHA® 40 mg/capsule
Take 2 capsules per day at any time.
DIETARY_SUPPLEMENTPlacebo
Take 2 capsules per day at any time.
Sponsors
BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED
Orthomedico Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose skin viscoelasticity is relatively low at screening (before consumption) 6. Subjects whose BMI are 23 kg/m\^2 or more and less than 30 kg/m\^2 7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray 8. Subjects whose WOMAC score is relatively high
Exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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 4. Subjects who use or take Foods for Specified Health Uses, or Foods with Functional Claims in daily 5. Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol) 8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 9. Subjects who suffer from COVID-19 10. 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 11. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each WOMAC subscale score at Week 12 | 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. |
| Subjective symptoms at Week 12 | 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. |
Countries
Japan
Outcome results
None listed