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

• Sponsor: Orthomedico Inc. (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05683327
• Collaborator: BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED (Other)
• Enrollment: 66
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 5.6
• Patients Per Site: 33
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Japanese Subjects	Dietary Supplement: UltraHA® 75 mg/capsule; Dietary Supplement: UltraHA® 40 mg/capsule; Dietary Supplement: Placebo	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study
• Anticipated Study Start Date: Jan 5, 2023
• Anticipated Primary Completion Date: Jun 25, 2023
• Anticipated Study Completion Date: Jun 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hyaluronic Acid 150 mg Take 150 mg/day of hyaluronic acid.	Dietary Supplement: UltraHA® 75 mg/capsule; Take 2 capsules per day at any time.
Active Comparator: Hyaluronic Acid 80 mg Take 80 mg/day of hyaluronic acid.	Dietary Supplement: UltraHA® 40 mg/capsule; Take 2 capsules per day at any time.
Placebo Comparator: Placebo Take 0 mg/day of hyaluronic acid.	Dietary Supplement: Placebo; Take 2 capsules per day at any time.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nerima Medical Association Minami-machi Clinic	Nerima-ku	Tokyo	Japan	176-0002
2	Medical Corporation Seishinkai, Takara Clinic	Shinagawa-Ku	Tokyo	Japan	141-0022

Sponsors and Collaborators

• Orthomedico Inc.
• BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED

Investigators

• Study Chair: Tsuyoshi Takara, MD, Medical Corporation Seishinkai, Takara Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orthomedico Inc.
• ClinicalTrials.gov Identifier: NCT05683327
• Other Study ID Numbers: 06793-0003-0E
• First Posted: Jan 13, 2023
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Orthomedico Inc.: Hyaluronic Acid; Knee

Study Results

No Results Posted as of Jan 17, 2023