UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058666 |
|---|---|
| Receipt number | R000067086 |
| Scientific Title | Evaluation of the Effects of the Test Food on Menstrual Symptoms: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 15:23:22 |
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Basic information
Public title
Evaluation of the Effects of the Test Food on Menstrual Symptoms
Acronym
Evaluation of the Effects of the Test Food on Menstrual Symptoms
Scientific Title
Evaluation of the Effects of the Test Food on Menstrual Symptoms: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study
Scientific Title:Acronym
Evaluation of the Effects of the Test Food on Menstrual Symptoms: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-NRS score for menstrual pain
Key secondary outcomes
Secondary outcomes:
-Menstrual Distress Questionnaire (MDQ) during menstruation
-WPAI-GH
Safety outcomes:
Incidence of adverse events and side effects
Other outcomes:
Background survey, medical interview, questionnaire on menstrual symptoms with menstrual pain as the main complaint, physical measurements, physiological tests, blood tests, transvaginal ultrasound examination, lifestyle survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
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.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese adult women
2. Experience discomfort such as menstrual pain during menstruation
3. Regular menstrual cycles (25-38 days) and periods lasting 3-7 days
4. Able to enter electronic diaries via smartphone or PC
5. Fully informed about the study and voluntarily consented in writing
Key exclusion criteria
1. Currently receiving treatment for any illness with medication or Kampo (as-needed use permitted)
2. Under dietary or exercise therapy supervised by a physician
3. Current or past gynecological disorders that may affect the study
4. Total score of 13 or higher on the questionnaire on menstrual symptoms with menstrual pain as the main complaint
5. Used oral contraceptives within 6 months before consent or plans to use during the study
6. Postmenopausal
7. Current or past organic gastrointestinal diseases (excluding appendicitis and hemorrhoids)
8. Current or past serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases
9. Regular use of over-the-counter drugs, quasi-drugs, specified health foods, health foods, or supplements (eligible if discontinued after consent and during the study)
10. Possible allergy to the test food
11. Shift workers with night shifts
12. Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study
13. Plans for overseas travel during the study
14. Habitual excessive alcohol consumption (>=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 sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Tsukamoto |
Organization
ROHTO PHARMACEUTICAL CO., LTD.
Division name
Internal Medicine and Functional Food Development Division Function Development Group
Zip code
544-8666
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka, Japan
TEL
06-6758-9848
kouseit@rohto.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
ROHTO PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ROHTO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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
| 2025 | Year | 08 | Month | 01 | 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 | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067086
