Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060115) titled 'Effect of food-derived ingredients on physical discomfort' on Dec. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of the food-derived ingredients on physical discomfort.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take low-dose capsules containing food-derived ingredients once daily for 8 weeks.
Interventions/Control_2 - Take medium-dose capsules containing food-derived ingredients once daily for 8 weeks.
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male and Female
Key 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.
Key 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.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 08 Day
Date of IRB - 2025 Year 12 Month 08 Day
Anticipated trial start date - 2026 Year 01 Month 27 Day
Last follow-up date - 2026 Year 05 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068741
Disclaimer: Curated by HT Syndication.
