UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037316 |
|---|---|
| Receipt number | R000042543 |
| Scientific Title | A study of the effectiveness of the milk component for menstrual symptoms |
| Date of disclosure of the study information | 2019/07/19 |
| Last modified on | 2020/06/26 11:56:04 |
* 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
A study of the effectiveness of the milk component for menstrual symptoms
Acronym
A study of the effectiveness of the milk component for menstrual symptoms
Scientific Title
A study of the effectiveness of the milk component for menstrual symptoms
Scientific Title:Acronym
A study of the effectiveness of the milk component for menstrual symptoms
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect on menstrual symptoms in continuous intake of milk components for 22 to 35 days coupled to menstrual cycle by performing the comparison with placebo group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of menstrual symptoms survey items
Key secondary outcomes
- Physical symptom score of menstrual symptoms survey items
- Psychological symptoms score of menstrual symptoms survey items
- VAS for menstrual pain
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1) Ingestion of study food substance: from 8th day of last menstruation started to 4th day of second menstruation started
2) Break period :from 5th day of second menstruation started to 7th day of third menstruation started
3) Ingestion of control food substance:from 8th day of third menstruation started to 4th day of fourth menstruation started
Interventions/Control_2
1) Ingestion of control food substance: from 8th day of last menstruation started to 4th day of second menstruation started
2) Break period :from 5th day of second menstruation started to 7th day of third menstruation started
3) Ingestion of study food substance:from 8th day of third menstruation started to 4th day of fourth menstruation started
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1) Subjects who received adequate explanation of the purpose and contents of this clinical trial volunteered with sufficient consent, voluntarily volunteered with voluntary understanding, agreed to participate in the document.
2) Subjects who are healthy female between 25 and 40 years old at the point of obtaining informed consent.
3) Subjects with 25 to 38 days menstrual cycle in the latest 6 menses and the menstrual duration is 3 to 7 days.
4) Subjects with menstrual symptoms from 3th day before menstruation strated to 3th day of menstruation strated.
Key exclusion criteria
1) Pregnant, lactating women or willing to be pregnancy during the study
2) Subjects who are willing to become pregnant during this study
3) Subjects who have histories of gynecologic disorder or have gynecologic disorder
* Gynecologic disorder: Secondary amenorrhea, Dysmenorrhea, Endometriosis, Fibroid, Premenstrual dysphoric disorder (PMDD , Breast cancer, Cervical cancer, Uterine body cancer, Ovary cancer etc.
4) Subject with allergy to milk, wheat, egg, shrimp, crab, or subjects with lactose intolerance
5) Subjects who had participated in other clinical trials or monitoring studies within 2 month prior to obtaining informed consent
6) Subjects without menstruation pain, or subjects with severe menstruation pain and unable to control the pain by taking over-the-counter analgesic medication
7) Subjects classified as psychosomatic (Type IV) by CMI health questionnaire
8) Subjects with a score of 20 and above for the stress score by Brief Stress Level Check List
9) Subjects whose total score of menstrual symptoms survey items at the point of postmenstrual period is 1 or more points higher compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items (preliminary survey)
10) Subject who is ineligible for this study due to medical doctor's judgement
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamaguchi |
Organization
Meiji Co., Ltd.
Division name
Group1, Health Science Research Department, Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5849
makoto.yamaguchi@meiji.com
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
153-0053
Address
Gohongi 3-13-16 Meguro-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
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 19 | 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
| 2019 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 01 | 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
| 2019 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042543
