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Completed

NCT Number: NCT05683327

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

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

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Key information

Conditions

Healthy Japanese Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nerima Medical Association Minami-machi Clinic, Nerima-ku, Tokyo, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

UltraHA® 75 mg/capsule

Dietary Supplement

Take 2 capsules per day at any time.

UltraHA® 40 mg/capsule

Dietary Supplement

Take 2 capsules per day at any time.

Placebo

Dietary Supplement

Take 2 capsules per day at any time.

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12

    Time frame: 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 outcomes

  1. Each WOMAC subscale score at Week 12

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orthomedico Inc.

Other

Collaborators

  • BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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