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

NCT05683327 | Completed DMC

• 1 other identifier: 06793-0003-0E
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.

Conditions

Healthy Japanese Subjects

Keywords

Hyaluronic Acid; Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (2)

• Each WOMAC subscale score at Week 12

  Week 12

• Subjective symptoms at Week 12

  Week 12

Study Arms (3)

Hyaluronic Acid 150 mg

ACTIVE COMPARATOR

Take 150 mg/day of hyaluronic acid.

Dietary Supplement: UltraHA® 75 mg/capsule

Hyaluronic Acid 80 mg

ACTIVE COMPARATOR

Take 80 mg/day of hyaluronic acid.

Dietary Supplement: UltraHA® 40 mg/capsule

Placebo

PLACEBO COMPARATOR

Take 0 mg/day of hyaluronic acid.

Dietary Supplement: Placebo

Interventions

UltraHA® 75 mg/capsule DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Hyaluronic Acid 150 mg

UltraHA® 40 mg/capsule DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Hyaluronic Acid 80 mg

Placebo DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Orthomedico Inc.: lead
• BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED: collaborator

Study Sites (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, 176-0002, Japan

Location

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-Ku, Tokyo, 141-0022, Japan

Location

Study Officials

• Tsuyoshi Takara, MD

  Medical Corporation Seishinkai, Takara Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: January 6, 2023
• Primary Completion: June 24, 2023
• Study Completion: June 24, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)