UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053169 |
|---|---|
| Receipt number | R000060678 |
| Scientific Title | A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation |
| Date of disclosure of the study information | 2023/12/22 |
| Last modified on | 2024/01/19 10:09:59 |
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Basic information
Public title
A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation
Acronym
A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation
Scientific Title
A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation
Scientific Title:Acronym
A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of the study beverage in terms of unidentified complaints associated with menstruation when continuously consumed during a period linked to the menstrual cycle by comparison with a control group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total score of Menstrual Associated Symptoms Questionnaire
Key secondary outcomes
1)Menstrual Associated Symptoms Questionnaire Physical Symptom Score
2)Menstrual Associated Symptoms Questionnaire Psychological Symptom Score
3)Health Status Questionnaire
4)Sleep-Related Questionnaire
5)Skin and Hair Questionnaire
6)Degree of menstrual pain
7)Basal Body Temperature
8)Hormone Test
9)Skin moisture content, skin oil content
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of study beverage for 3 menstrual cycles
Interventions/Control_2
Consumption of control beverage for 3 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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Premenopausal healthy adult females aged 20 to 40
2) Subject whose menstrual cycles, calculated from the last 6 menstrual cycles, are within the range of 25 to 38 days and whose usual menstrual duration is 3 to 7 days.
3) Subject with symptoms of discomfort from about 3 days before the start of menstruation to about the 3rd day of menstruation.
4) Subject who can use electronic diary application (e-DCA)
5) Subject who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Key exclusion criteria
1)Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system
2)Subject who is under medication on a steady basis or history of medication for serious disorders
3)Subject currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy)
4)Subject with gynecological disorders (secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, uterine body cancer, ovarian cancer, etc.)
5)Subject who has difficulty drinking study beverage
6)Subject who takes medications and supplements on a daily basis *Except subject who can cancel an intake of health foods and supplements during this trial
7)Subject who has no menstrual discomfort symptoms at all, do not use over-the-counter pain relievers at all when symptoms are present, or whose symptoms are severe and cannot be controlled with over-the-counter pain relievers.
8)Subject who is pregnant, lactating mother, or who is willing to become pregnant during this trial
9)Any candidates considered to be ineligible for enrollment due to the results of health condition questionnaire
10)Subject who took part in the other clinical/monitoring trial within a month before giving informed consent to take part in this trial.
11)Subject with area IV on the Neuroticism Discriminant Chart of the CMI Health Questionnaire
12)Those whose total score on the Postmenstrual Associated Symptom Questionnaire is 0 points or higher than the total score on the Premenstrual Associated Symptom Questionnaire or the total score on the Menstrual Associated Symptom Questionnaire during menstruation, regarding the Menstrual Associated Symptoms Questionnaire (pre-survey).
13)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548541247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
150-0002
Address
Shibuya 1-4-7 Shibuya-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.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
茅場町こころのケアクリニック（東京都）/Kayaba-cho Mental Health Care Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 22 | 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
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060678
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