UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060336 |
|---|---|
| Receipt number | R000069018 |
| Scientific Title | Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms |
| Date of disclosure of the study information | 2026/01/13 |
| Last modified on | 2026/01/13 14:24:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms
Acronym
Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms
Scientific Title
Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms
Scientific Title:Acronym
Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect of repeated use of steam heat sheets before menstruation on alleviating menstrual-associated symptoms
Basic objectives2
Others
Basic objectives -Others
To determine the optimal duration of application of steam heat sheets to the lower abdomen for alleviating menstrual-associated symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Menstrual-associated symptoms (pain) according to the duration of steam heat sheet application (7 days, 1 day, no application).
Key secondary outcomes
Differences in menstrual-associated symptoms (non-pain symptoms), and in expressions used to describe pain and perceived effectiveness (subjective descriptors of effect), according to the duration of steam heat sheet application (7 days, 1 day, no application).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3297-0978
fukagawa.satoko@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Tsunoda |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-70-3296-8210
Homepage URL
tsunoda.mai@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131- 8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069018
