Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test material: Fushi-jiman (gel type) Administration: Massage with an appropriate amount of the test material at least twice a day (when getting up and after taking a bath, for exa
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are experiencing discomfort in the knee joint 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before test-material application) 5. Within the subjects who met the 4th inclusion criteria, subjects whose total scores of JKOM are relatively high at screening (before test-material application)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are undergoing medical treatment of knee disease such as knee osteoarthritis 6. Subjects who are currently taking medications (including herbal medicines, compresses, and external medicines) and supplement 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 10. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the total score of Japanese Knee Osteoarthritis Measure (JKOM) 1. The change of the pre-use values between at screening (before test-material application; Scr) or the start day of the test-material application (0w) and four weeks after the start of test-material application (4w) 2. The change of the values between at Scr or 0w (pre-use) and three weeks after the start of test-material application 3. The change of the values between at Scr or 0w (pre-use) and two weeks after the start of test-material application 4. The change of the values between at Scr or 0w (pre-use) and one week after the start of test-material application 5. The change of the values between at Scr or 0w (pre-use) and three days after the start of test-material application 6. The change between pre-use and one-hour-after values at 0w 7. The change between pre-use and one-hour-after values at 4w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The score of visual analogue scale (VAS; JKOM) 2. The score of pain in knees (JKOM) 3. The score of stiffness in knees (JKOM) 4. The score of condition in daily life (JKOM) 5. The score of general activities (JKOM) 6. The score of health conditions (JKOM) 7. Individual items of the JKOM questionnaire 8. Customized questionnaire (the Likert scale) *1-6 The changes calculated at the same points as the primary outcome *7, 8 The pre-use values at Scr, 0w, three days and one, two, three, and four weeks after the start of test-material application, and one-hour-after values at 0w and 4w | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed