Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing methyl sulfonyl methane Administration: Take ten tablets per day with water, five tablets each at breakfast and dinner * If you forget to take the t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are experiencing discomfort in the knee joint 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr) 8. Subjects whose JKOM score are relatively high at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are undergoing medical treatment of knee disease such as knee osteoarthritis 4. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 6. Subjects who currently taking or using medicines (include herbal medicines, cold patch and topical medication) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant 9. 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 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of the total score of Japanese Knee Osteoarthritis Measure (JKOM) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the total score of JKOM at 4 and 8 weeks after consumption (4, 8w) 2. The amounts of changes of the total score of JKOM between screening (before consumption; Scr) and 4w, 8w, or 12w 3. The measured values at 4w, 8w and 12w and amounts of changes between Scr and 4w, 8w, or 12w of the following items: 3-1. JKOM visual analogue scale (VAS), the scores of pain and stiffness in knees, conditions in daily life, general activities, and health conditions 3-2. Japanese Orthopaedic Association (JOA) score JOA score [average of both foot (right and left), left foot, and right foot], pain on walking [average of both foot (right and left), left foot, and right foot], pain on ascending or descending stairs [average of both foot (right and left), left foot, and right foot], range of motion [average of both foot (right and left), left foot, and right foot], joint effusion [average of both foot (right and left), left foot, and right foot] 3-3. Interleukin 1 beta (IL-1beta) 3-4. Interleukin 6 (IL-6) 3-5. High sensitivity C-reactive protein (CRP) 3-6. Procollagen II C-Terminal Propeptide (PIICP) 3-7. Collagen Type II Cleavage (C2C)* 4. The values of the individual items of the JKOM questionnaire and the JOA score at 4w, 8w and 12w *Due to the outbreak of COVID-19 infection, the measurement of the originally planned marker is no longer feasible and thereby the measuring marker has been changed. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed