The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function

NCT ID: NCT05683327

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2023-06-24

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.

Conditions

Healthy Japanese Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hyaluronic Acid 150 mg

Take 150 mg/day of hyaluronic acid.

Group Type: ACTIVE_COMPARATOR

UltraHA® 75 mg/capsule

Intervention Type: DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Hyaluronic Acid 80 mg

Take 80 mg/day of hyaluronic acid.

Group Type: ACTIVE_COMPARATOR

UltraHA® 40 mg/capsule

Intervention Type: DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Placebo

Take 0 mg/day of hyaluronic acid.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Interventions

UltraHA® 75 mg/capsule

Take 2 capsules per day at any time.

Intervention Type: DIETARY_SUPPLEMENT

UltraHA® 40 mg/capsule

Take 2 capsules per day at any time.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Take 2 capsules per day at any time.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED

UNKNOWN

Sponsor Role: collaborator

Orthomedico Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsuyoshi Takara, MD

Role: STUDY_CHAIR

Medical Corporation Seishinkai, Takara Clinic

Locations

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, Japan

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-Ku, Tokyo, Japan

Countries

Japan

Other Identifiers

06793-0003-0E

Identifier Type: -

Identifier Source: org_study_id