Clinical trial NCT05683327: The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function
Official title: The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Japanese Subjects
Keywords: Hyaluronic Acid
Knee
Lead sponsor: Orthomedico Inc.
Sponsor class: OTHER
Collaborators: name: BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED
First posted: 2023-01-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Each WOMAC subscale score at Week 12
timeFrame: Week 12
measure: Subjective symptoms at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Nerima-ku
country: Japan
facility: Nerima Medical Association Minami-machi Clinic
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Medical Corporation Seishinkai, Takara Clinic
state: Tokyo
Study officials:
affiliation: Medical Corporation Seishinkai, Takara Clinic
name: Tsuyoshi Takara, MD
role: STUDY_CHAIR
References: