Clinical Trial: Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms (Japan)

Tokyo, Jan. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060336) titled 'Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms' on Jan. 13.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kao Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms Basic objectives2 - Others

Intervention: Interventions/Control_1 - In menstrual cycle 1, apply a steam heat sheet to the lower abdomen for 8 hours per day for 7 consecutive days (daily for 7 days, starting 7 days before the expected Day 2 of menstruation). Cycle 2: washout (no application). In menstrual cycle 3, apply a steam heat sheet to the lower abdomen for 8 hours on a single day (Day 2 of menstruation). Interventions/Control_2 - In menstrual cycle 1, apply a steam heat sheet to the lower abdomen for 8 hours on a single day (Day 2 of menstruation). Cycle 2: washout (no application). In menstrual cycle 3, apply a steam heat sheet to the lower abdomen for 8 hours per day for 7 consecutive days (daily for 7 days, starting 7 days before the expected Day 2 of menstruation).

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1. Females aged 20-49 years. 2. Regular menstrual cycles (cycle length 25-38 days, with month-to-month variability generally within <=3 days) and able to report the dates/durations of the three most recent menstrual periods. 3. Self-reported mild menstrual-associated symptoms (symptoms that do not interfere with daily activities or work). Key exclusion criteria - 1. Currently receiving outpatient care, taking medication for, or with a history of gynecological disorders (e.g., dysmenorrhea, uterine fibroids, adenomyosis, endometriosis, cervical intraepithelial neoplasia, cervical cancer, etc.). 2. Regular use of analgesics (including over-the-counter medications) during the premenstrual or menstrual phase. 3. Presence of hepatic, renal, cardiac, respiratory, endocrine, metabolic (e.g., hypertension), neurological disorders, disorders of consciousness, diabetes, or other medical conditions that would preclude participation in the study. 4. Received medication therapy or surgery for a serious illness or injury within one month prior to study initiation and judged by the principal investigator or study staff to be unsuitable for participation. 5. Receiving hormone replacement therapy (HRT) or taking medications that may affect hormonal status (including oral contraceptives). 6. Pregnant, breastfeeding, or planning to become pregnant during the study period. 7. History of eczema or urticaria induced by steam-heat stimulation. 8. Impaired thermal sensation or hypersensitivity to temperature. 9. Any other condition judged by the principal investigator or study staff to render the participant unsuitable for the study. 10. Participation in another clinical trial of drugs or food products within the past month, or planned participation in such a trial during this study. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 26 Day Date of IRB - 2026 Year 01 Month 07 Day Anticipated trial start date - 2026 Year 01 Month 13 Day Last follow-up date - 2026 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069018

Disclaimer: Curated by HT Syndication.