Healthy adult
Conditions
Interventions
SM-10 supplements are ingested for 12 consecutive weeks at 600 mg.
Placebo are ingested for 12 consecutive.
Sponsors
TTC CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females at the ages of 45 to 64 2. Subjects who confirmed pain of knee joint by JKOM and VAS. 3. Subjects who are judged as stage 1 in locomotive syndrome risk test 4. Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Exclusion criteria
Exclusion criteria: 1. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability 2. Subjects who are suspected gouty attack with hyperuricemia 3. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain 4. Subjects who have performed arthroplasty or need it 5. Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study 6. Subjects who regularly take medicine 7. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test 8. Subjects who get an intense exercise to make excessive load on the joints 9. Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test 10. Subjects who regularly use a stick or supporter 11. Subjects who routinely exert an influence on the efficacy evaluation 12. Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease 13. Subjects who consume an excess amounts of alcohol 14. Subjects who have possibility of allergy symptoms onset by the test supplement 15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 16. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period 17. Subjects who intend to become pregnant or lactating 18. Subjects who are judged as unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of change in locomotive syndrome risk test at 6 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of change in JKOM, JHEQ, JLEQ, JOA, VAS (knee pain), COMP, liver function (AST, ALT, gamma-GTP). Levels of change in knee joint stiffness. | — |
Countries
Japan
Contacts
Public ContactSayuri Fujita
Horus Co., Ltd. Academic Planning Department
Outcome results
None listed