Healthy Japanese
Conditions
Sponsors
ICHIMARU PHARCOS Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals who are concerned about the shoulder joint 6. Individuals whose JOA score of the shoulder joint is relatively low shoulder joint JOA scores (>=60 points) at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to salmon or gelatin 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who usually use (e.g., glucosamine hydrochloride, chondroitin, collagen peptide, hyaluronic acid, or DHA / EPA) that affect the joint 10. Individuals who plan to start exercise that put intense stress on the joint 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the Japanese Orthopaedic Association (JOA) score of the shoulder joint at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of pain score of shoulder joint, function score of shoulder joint, range of motion (active) score of shoulder joint, X-ray evaluation score of shoulder joint, stability score of shoulder joint, and Visual Analogue Scale (VAS) at 12w 2. Individuals who experienced adverse events 3. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr) 4. Physical measurements, urine test, peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed