Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058666) titled 'Evaluation of the Effects of the Test Food on Menstrual Symptoms' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - ROHTO PHARMACEUTICAL CO., LTD.
Condition:
Condition - Healthy Japanese subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous intake of the test food over three menstrual cycles on menstrual pain in healthy premenopausal adult women who experience menstrual pain.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will take the test food, starting from day 8 of menstruation and continuing until the final visit after three menstrual cycles.
Interventions/Control_2 - Participants will take the placebo food, starting from day 8 of menstruation and continuing until the final visit after three menstrual cycles.
Eligibility:
Age-lower limit - 18
years-old
=40g/day)
15. Excessive smoking
16. Currently pregnant, breastfeeding, wishing to become pregnant during the study, or possibly pregnant
17. Participation in another clinical study within 3 months before consent, currently participating, or planning to participate during the study
18. Deemed unsuitable for the study by the principal investigator
Target Size - 160
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 29 Day
Anticipated trial start date - 2025 Year 11 Month 08 Day
Last follow-up date - 2026 Year 05 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067086
Disclaimer: Curated by HT Syndication.
