UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048186 |
|---|---|
| Receipt number | R000054914 |
| Scientific Title | Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation -double-blind, parallel-group comparison trial- |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2024/05/20 15:46:22 |
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Basic information
Public title
Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation
-double-blind, parallel-group comparison trial-
Acronym
Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation
-double-blind, parallel-group comparison trial-
Scientific Title
Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation
-double-blind, parallel-group comparison trial-
Scientific Title:Acronym
Study on the effect of continuous intake of test foods on physical and psychological discomfort concerning menstruation
-double-blind, parallel-group comparison trial-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of intake of test foods on physical and psychological discomfort during pre-menstruation and menstruation in healthy female aged between 20 and less than 40 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSQ, Premenstrual Symptoms Questionnaire.
Key secondary outcomes
MDQ, Menstrual Distress 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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one capsule of test food after breakfast once a day for 12 weeks.
Interventions/Control_2
Take one capsule of placebo food after breakfast once a day for 12 weeks.
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. Aged between 20 and less than 40 years old.
2. Japanese females.
3. BMI is less than 30.0 kg/m2.
4. Individuals whose menstruation cycle is stable for recent 3 months (21-35 days cycle, 3-7 days menstruation period).
5. Individuals who have any psychological or physical discomfort during pre-menstruation and menstruation.
6. Individuals who can use smartphones or PCs to input an electronic diary.
7. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Individuals who are currently undergoing treatment for any disease or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed including antipyretic analgesic are acceptable.
2. Individuals who have received any endocrine therapy in past 3 months.
3. Individuals who have been diagnosed as PMDD, or have symptoms of PMDD.
4. Individuals who are receiving nutritional and exercise therapy by medical doctors.
5. Individuals who have any severe disease or any severe symptoms, or history of severe diseases.
6. Individuals who have any digestive disease, or history of any digestive diseases, except appendicitis.
7. Individuals who have taken foods or used products including pycnogenol.
8. Individuals who have any psychologically stressful events, including death of whose relatives or friends, whose or whose parents' divorce, financial hardship, or accident, in past 3 months.
9. Individuals who have regularly been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims.
10. Individuals who have allergies to drugs or foods.
11. Individuals who are planning extremely change lifestyle (such as diet, sleep, or exercise) during the study.
12. Individuals who are planning travel to foreign countries during the study period.
13. Currently pregnant or breastfeeding, or planning to pregnant during the study.
14. Individuals who donated blood more than 400 mL in past 3 months or 200 mL in past one month before screening date.
15. Shift workers.
16. Taking more than 60 g alcohol/day.
17. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the study.
18. Individuals who are unsuitable for the study, that judged by the principal investigator.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
HigashiKoganei Sakura Clinic
Division name
Hospital director
Zip code
184-0011
Address
4-37-26 Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
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
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Horphag Research
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
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
| 2023 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054914
