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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024674
Receipt No. R000028388
Scientific Title Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Date of disclosure of the study information 2016/11/01
Last modified on 2017/01/05

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Basic information
Public title Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Acronym Effect of ingestion of Moringa oleifera leaves on improving constipation.
Scientific Title Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Scientific Title:Acronym Effect of ingestion of Moringa oleifera leaves on improving constipation.
Region
Japan

Condition
Condition Healthy adult female with a tendency for constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation days,defecation frequency,fecal amount
Key secondary outcomes Fecal shape,fecal color,fecal odor,feeling after defecation,intestinal microflora

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects ingested the placebo powder for 2 weeks, after 2 weeks, ingested the Moringa oleifera leaves powder for 2 weeks.
Interventions/Control_2 The subjects ingested the Moringa oleifera leaves powder for 2 weeks, after 2 weeks, ingested the placebo powder for 2 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
50 years-old >
Gender Female
Key inclusion criteria 1.Subjects whose defecation frequency is no fewer than 3, nor more than 6,

2.Subjects who not consume higher amount of alcohol

3.Subjects whose meal times are three a day usually.
Key exclusion criteria 1.Subjects who regularly use intestinal drug and laxatives(including strong laxatives).

2.Subjects who can not stop intake higher amount of food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or the health food to relieve constipation during the screening period.


3.Subjects who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement.

4.Subjects who is pregnant or willing to be pregnant or breast-feeding during this study.

5.Subjects who are judged unsuitable for this study by test responsibility doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mihoko Moto
Organization Wayo Women's University
Division name Department of Health and Nutrition
Zip code
Address 2-3-1 konodai, Ichikawa, Chiba, 272-8533 Japan
TEL 047-371-2393
Email moto@wayo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mihoko Moto
Organization Wayo Women's University
Division name Department of Health and Nutrition
Zip code
Address 2-3-1 konodai, Ichikawa, Chiba, 272-8533 Japan
TEL 047-371-2393
Homepage URL
Email moto@wayo.ac.jp

Sponsor
Institute Wayo Women's University
Institute
Department

Funding Source
Organization iGUAZU Corporation
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
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 11 Month 01 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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 01 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028388

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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