None listed
Conditions
Interventions
Take tablets containing food-derived ingredients once daily for 8 weeks.
Take placebo tablets once daily for 8 weeks.
Sponsors
Kao Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must be Japanese, aged 30-59, and meet either of the following criteria (n = 80): 1 Participants who experience stiffness and tension in the neck and shoulders, as well as in the lower back (n = 40 for 2 groups): Experience stiffness, tension, or pain in the neck and shoulders at least twice a week for more than 3 months. A VAS (Visual Analogue Scale) score of 40 or higher for discomfort (stiffness, tension, pain) in the neck and shoulders (with 100 being the maximum). Experience stiffness, tension, or pain in the lower back at least twice a week for more than 3 months. A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the lower back (with 100 being the maximum). A score of 20 or higher on the Japanese Lumbar Evaluation Questionnaire (JLEQ). 2 Participants who experience stiffness and tension in the neck and shoulders, as well as neuropath ic pain in the lower back (n = 40 for 2 groups): Experience stiffness, tension, or pain in the neck and shoulders at least twice a week for more than 3 months. A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the neck and shoulders (with 100 being the maximum). Experience stiffness, tension, or pain in the lower back at least twice a week for more than 3 months. A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the lower back (with 100 being the maximum). A score of 20 or higher on the Japanese Lumbar Evaluation Questionnaire (JLEQ). A score of 6 or higher on the Neuropathic Pain Questionnaire, with preference given to those with higher scores.
Exclusion criteria
Exclusion criteria: 1. Individuals currently attending a hospital to treat stiffness, tension, or pain in the neck, shoulders, or lower back, or those using oral or topical medications (including patches) for such purposes. 2. Individuals who have undergone surgical procedures on the neck, shoulders, or lower back. 3. Individuals diagnosed by a physician with a condition related to stiffness, tension, or pain in the neck, shoulders, or lower back. 4. Individuals with hyperuricemia and a history of gout attacks. 5. Individuals with a history of rheumatoid arthritis. 6. Individuals taking health foods or supplements (such as vitamins) related to relieving stiffness or tension. 7. Individuals engaging in activities (such as massage, chiropractic, or acupuncture) that might affect the evaluation of effectiveness. 8. Individuals with serious diseases affecting the liver, kidneys, heart, lungs, digestive system, blood, endocrine system, or metabolism. 9. Individuals diagnosed with cardiovascular-related diseases such as arteriosclerosis, angina, or arrhythmia, or with mental health disorders such as depression. 10. Individuals who have suffered severe musculoskeletal injuries (such as fractures, tendon ruptures, or muscle strains) within one year prior to study participation. 11. Individuals using canes, braces, or corsets. 12. Individuals with impairments affecting the measurement of musculoskeletal function. 13. Pregnant women, those who may be pregnant, nursing mothers, or those planning to become pregnant during the study period. 14. Individuals participating in other clinical trials involving pharmaceuticals or foods, or those planning to participate in another study during the cooperation period of this study.
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 | — |
Countries
Japan
Contacts
Public ContactSatoshi Sugita
Kao Corporation Human Health Care Research Lab.
Outcome results
None listed