Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058657) titled 'A placebo-controlled, randomized, double-blind, parallel-group comparative study on the effects of continuous intake of test foods on premenstrual syndrome (PMS) in healthy women' 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 - Macromill, Inc.

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A placebo-controlled, randomized, double-blind, parallel-group comparative trial was conducted on women aged 20 to 40 with normal menstrual cycles and premenstrual syndrome to examine the effects of continuous administration of the test product for one menstrual cycle on premenstrual syndrome. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Take the test food for one menstrual cycle. Interventions/Control_2 - Take placebo food for one menstrual cycle.

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - (1) Women aged 20 to 40 at the time of obtaining consent to participate in the trial (2) Individuals with a normal menstrual cycle (the last three menstrual cycles were 25 to 38 days, and the menstrual period was 3 to 7 days) (3) Individuals with recognized premenstrual syndrome (PMS) symptoms (4) Individuals who have received adequate explanation of the purpose and content of this trial, possess the capacity to consent, have fully understood the information, voluntarily enrolled in the trial of their own free will, and whose consent can be obtained through electronic informed consent. Key exclusion criteria - (1) Regular use of medications affecting premenstrual symptoms (e.g., oral contraceptives, hormones, OTC remedies), excluding temporary use of painkillers, laxatives, or antidiarrheals during the premenstrual period or menstruation. (2) Under treatment or planning treatment for PMS, PMDD, dysmenorrhea, other gynecological, thyroid, autonomic, or mental disorders. (3) History of gynecological disorders. (4) History of mental disorders. (5) Chronic conditions under treatment (e.g., anemia, allergies, asthma, diabetes, hyperlipidemia, hypertension). (6) History of major gastrointestinal surgery or serious GI disease (excluding appendectomy), or under GI treatment. (7) Pregnant, possibly pregnant, breastfeeding, or planning pregnancy during the study. (8) Allergic to the study product. (9) Regular use of health foods or supplements that cannot be discontinued. (10) Heavy smokers (21 or more cigarettes per day). (11) Regular alcohol consumption (60 g/day or more, 6 or more days/week). (12) Irregular sleep or eating habits (e.g., night or shift work). (13) Anticipated major changes in living, diet, or exercise during the trial. (14) Participation in another clinical trial within 4 weeks or during the study period. (15) Judged ineligible by the investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 24 Day Date of IRB - 2025 Year 07 Month 24 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067069

Disclaimer: Curated by HT Syndication.