Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: food containing a mixture of tamarind and turmeric (normal dose) Administration: Take two capsules per day after breakfast with water * Daily dose should be taken
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. Healthy subjects 3. Subjects who are experiencing discomfort in the knee and waist joints 4. Subjects who are judged as eligible to participate in the study by the physician 5. Within the subjects who met the 4th inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at Scr 6. Within the subjects who met the 5th inclusion criteria, subjects whose JKOM score are relatively high at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and 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 currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any 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 medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products, particularly turmeric and tamarind 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 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 value of the Japanese Knee Osteoarthritis Measure (JKOM) score at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of JKOM score at four weeks after consumption (4w) 2. The change of the JKOM score from screening (before consumption; Scr) to 4w and 8w 3. The measured values at 4w and 8w and amounts of changes from Scr to 4w and 8w of the following items: 3-1. JKOM visual analog scale (VAS), the score of pain and stiffness in knees, the score of condition in daily life, the score of general activities, and the score of health conditions 3-2. Japan Low Back Pain Evaluation Questionnaire (JLEQ) VAS, total score, low back pain related to activity of daily living, problems due to low back pain, and health and psychological condition 3-3. Japanese Orthopaedic Association (JOA) knee score JOA score [average of both foot (right and left), left foot, and right foot], pain on walkin g [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] 3-4. JOA lumbar spine score subjective symptoms score, objective symptoms score ,activities of daily living, and urinary bladder function 3-5. VAS score for leg pain 3-6. the number of times of standing up from the chair for 30 seconds 3-7. walking speed 3-8. the number of steps 3-9. stride length 3-10. waking rate 4. The values of the following items at 4w and 8w: individual items of the JKOM questionnaire, individual items of the JLEQ questionnaire, individual items of the JOA knee score, individual items of the JOA lumbar spine score | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed