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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022122
Receipt No. R000025478
Scientific Title Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms
Date of disclosure of the study information 2016/05/02
Last modified on 2017/01/08

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Basic information
Public title Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms
Acronym The effect of the indigestible dextrin on PMS
Scientific Title Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms
Scientific Title:Acronym The effect of the indigestible dextrin on PMS
Region
Japan

Condition
Condition Premenstrual syndrome
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of the indigestible dextrin on relief of PMS symptom due to slowing the postprandial elevation of blood glucose levels.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes symptoms from the first day of menstrual period to next period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Intervention: to drink indigestible dextrin-containing green tea at each meal during a menstrual cycle
5.12g of indigestible dextrin at each meal
Interventions/Control_2 Control: to drink indigestible dextrin-free green tea at each meal during a 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

Not applicable
Gender Female
Key inclusion criteria females who have a regular menstrual cycle
females who do not have a low-dose pill
females who is more than 20 years of age and older
Key exclusion criteria females who have an irregular menstrual cycle
females who take a low-dose pill
females who have no symptom
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Ohta
Organization International College of Arts and Sciences
Fukuoka Women's University
Division name Department of Food and Health Sciences
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL +81-92-661-2411
Email m-ohta@fwu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Ohta
Organization International College of Arts and Sciences, Fukuoka Women's University
Division name Department of Food and Health Sciences
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL +81-92-661-2411
Homepage URL
Email m-ohta@fwu.ac.jp

Sponsor
Institute Fukuoka Women's University
Institute
Department

Funding Source
Organization Fukuoka Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 05 Month 02 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
There is no significant effect of indigestible dextrin on the symptoms of PMS.
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
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 21 Day
Last follow-up date
2016 Year 08 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 27 Day
Date trial data considered complete
2016 Year 10 Month 24 Day
Date analysis concluded
2016 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 28 Day
Last modified on
2017 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025478

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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