UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058657 |
|---|---|
| Receipt number | R000067069 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/30 17:57:32 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) menstrual symptoms
Key secondary outcomes
(1) Premenstrual symptoms
(2) QOL questionnaire
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take the test food for one menstrual cycle.
Interventions/Control_2
Take placebo food for one menstrual cycle.
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
| 40 | 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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
TAIYO KAGAKU CO., LTD.
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
Institutional review board of Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067069
