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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037316
Receipt No. 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 2020/01/07

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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
Email 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
Email imai@levbrain.com

Sponsor
Institute Leverage Brain Inc.
Institute
Department

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
Email 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 No longer recruiting
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 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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