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

Healthy Japanese Subjects Clinical Trial

Official title:

The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05683327
• Other study ID #: 06793-0003-0E
• Status: Completed
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: June 24, 2023

Study information

• Verified date: January 2023
• Source: Orthomedico Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 24, 2023
• Est. primary completion date: June 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Japanese Subjects

Intervention

Dietary Supplement:
• UltraHA® 75 mg/capsule
Take 2 capsules per day at any time.
• UltraHA® 40 mg/capsule
Take 2 capsules per day at any time.
• Placebo
Take 2 capsules per day at any time.

Locations

Country	Name	City	State
Japan	Nerima Medical Association Minami-machi Clinic	Nerima-ku	Tokyo
Japan	Medical Corporation Seishinkai, Takara Clinic	Shinagawa-Ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Orthomedico Inc.	BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Each WOMAC subscale score 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 each subscale response is evaluated as the WOMAC subscale score.	Week 12
Secondary	Subjective symptoms at 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.	Week 12