Healthy subjects (Intended indications and effects: Improvement in discomfort of the knee joint)
Conditions
Interventions
Test food: Ginger extract powder
Duration: Eight weeks
Administration: Take one capsule per day in the morning.
Test food: Placebo
Duration: Eight weeks
Administration: Take one capsule per day in th
Sponsors
Takara Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who have agreed to participate and are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr) 6. The top 68 subjects with high Japanese Knee Osteoarthritis Measure (JKOM) score at Scr among those who have agreed to participate and meet inclusion criteria No.1~5 and 7 without meeting any of exclusion criteria 7. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, or any other heart disease 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatoid arthritis, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" 5. Subjects who are taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. 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 9. Subjects who usually use "Foods for Specified Health Uses," or "Foods with Functional Claims" that affect the knee joint {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide} 10. Subjects who engage in strenuous physical activity {e.g. ball sports (such as soccer, baseball, basketball), jogging, running, skiing, snowboarding} that places a load on the joints 11. Subjects who use a cane or joint support, or may use them during this trial 12. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of JKOM score at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of each item of the JKOM {visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, health conditions}, total score of the 25-question geriatric locomotive function scale (GLFS-25), two-step value in the two-step test, and high-sensitivity C-reactive protein (CRP) at 8w 2. The measured values of height of standing up on both legs and one leg in the stand-up test at 8w 3. The measured values of each item of the JKOM and GLFS-25, and degree of locomotive syndrome assessed by GLFS-25, the stand-up test, and the two-step test at 8w | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed