Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05683327
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2023-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12', 'timeFrame': 'Week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Each WOMAC subscale score at Week 12', 'timeFrame': 'Week 12', 'description': '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.'}, {'measure': 'Subjective symptoms at Week 12', 'timeFrame': 'Week 12', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic Acid', 'Knee'], 'conditions': ['Healthy Japanese Subjects']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Japanese\n2. Men or women\n3. Adults\n4. Healthy subjects\n5. Subjects whose skin viscoelasticity is relatively low at screening (before consumption)\n6. Subjects whose BMI are 23 kg/m\\^2 or more and less than 30 kg/m\\^2\n7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray\n8. Subjects whose WOMAC score is relatively high\n\nExclusion Criteria:\n\n1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction\n2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)\n3. 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\n4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily\n5. Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate\n6. Subjects who are currently taking medications (including herbal medicines) and supplements\n7. Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol)\n8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial\n9. Subjects who suffer from COVID-19\n10. 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\n11. Subjects who are judged as ineligible to participate in this study by the physician'}, 'identificationModule': {'nctId': 'NCT05683327', 'briefTitle': 'The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function', 'organization': {'class': 'OTHER', 'fullName': 'Orthomedico Inc.'}, 'officialTitle': 'The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '06793-0003-0E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic Acid 150 mg', 'description': 'Take 150 mg/day of hyaluronic acid.', 'interventionNames': ['Dietary Supplement: UltraHA® 75 mg/capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic Acid 80 mg', 'description': 'Take 80 mg/day of hyaluronic acid.', 'interventionNames': ['Dietary Supplement: UltraHA® 40 mg/capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Take 0 mg/day of hyaluronic acid.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'UltraHA® 75 mg/capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 2 capsules per day at any time.', 'armGroupLabels': ['Hyaluronic Acid 150 mg']}, {'name': 'UltraHA® 40 mg/capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 2 capsules per day at any time.', 'armGroupLabels': ['Hyaluronic Acid 80 mg']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 2 capsules per day at any time.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '176-0002', 'city': 'Nerima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nerima Medical Association Minami-machi Clinic'}, {'zip': '141-0022', 'city': 'Shinagawa-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Seishinkai, Takara Clinic'}], 'overallOfficials': [{'name': 'Tsuyoshi Takara, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Corporation Seishinkai, Takara Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing will be discussed among the research affiliates after the study is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthomedico Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}