UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Title of the study (Brief title)	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	Mihoko Moto
Organization	Wayo Women's University
Division name	Department of Health and Nutrition
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	Mihoko Moto
Organization	Wayo Women's University
Division name	Department of Health and Nutrition
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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