None listed
Conditions
Interventions
Take low-dose capsules containing food-derived ingredients once daily for 8 weeks.
Take medium-dose capsules containing food-derived ingredients once daily for 8 weeks.
Take high-dose capsules contain
Sponsors
Kao Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese adults aged 30-59 years. Experiencing discomfort in the neck or shoulders, as well as the lower back, at least twice per week for 3 months or longer. Visual analog scale (VAS) score of 40 or higher for neck or shoulder discomfort, and VAS of 40 or higher for low-back discomfort. Japan Low back pain Evaluation Questionnaire (JLEQ) score of 20 or higher.
Exclusion criteria
Exclusion criteria: 1. Those who are currently visiting a hospital to treat discomfort in the neck, shoulders, or lower back, or who used oral or topical medications (including medicated patches) for such discomfort within 1 month prior to study participation. 2. Those who underwent procedures that could affect efficacy assessment (e.g., massage, chiropractic/osteopathic bodywork, acupuncture) within 1 month prior to study participation. 3. Those who took health foods or supplements related to discomfort (e.g., B vitamins) within 1 month prior to study participation. 4. Those who have undergone surgery on the neck, shoulders, or lower back. 5. Those diagnosed by a physician with a disorder related to neck, shoulder, or lower back discomfort. 6. Those with a history of diabetes, rheumatoid arthritis, shingles, or hyperuricemia. 7. Those with serious diseases of the liver, kidneys, heart, lungs, gastrointestinal tract, blood, endocrine system, or metabolism. 8. Those who have been diagnosed with cardiovascular diseases such as arteriosclerosis, angina, or arrhythmia, or with psychiatric disorders such as depression. 9. Those who sustained severe musculoskeletal injuries (e.g., fracture, tendon rupture, muscle strain) within 1 year prior to study participation. 10. Those who use a cane, supports/braces, or a corset/back brace. 11. Those for whom musculoskeletal measurements would be difficult or hindered. 12. Those with excessively high intake of coffee, green tea, or black tea. 13. Pregnant women; those who may be pregnant; breastfeeding women; and those who intend to become pregnant during the study period. 14. Those who participated in other clinical trials of drugs or foods within 1 month prior to study participation, or who plan to participate in another study during this study. 15. Those who have difficulty taking capsules. 16. Those with a score of 6 or higher on a neuropathic pain questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JLEQ scores after 8 weeks of food-derived ingredients (analysis of covariance with pre-measurement scores as covariate) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS for neck, shoulder, and lower back discomfort | — |
Countries
Japan
Contacts
Public ContactSatoshi Sugita
Kao Corporation Human Health Care Research Lab.
Outcome results
None listed