UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of burdock tea on intestinal environment in subjects with a tendency toward constipation: a randomized, double-blind, placebo-controlled, cross-over trial.
Title of the study (Brief title)	Effect of burdock tea on intestinal environment in subjects with a tendency toward constipation
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intervention withburdock tea in subjects with a tendency of constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency and days of defecation.
Key secondary outcomes	Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured.

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	Treatment
Type of intervention	Food
Interventions/Control_1	A test drink per day for 2 weeks.
Interventions/Control_2	A placebo drink per day 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	People whose defecation frequency per two weeks is more than 10
Key exclusion criteria	1. Subjects with food allergies 2. Subjects who are pregnant or lactating 3. Subjects who consume medicinal product which may influence the outcome of the study 4.Subjects who consume food which may influence the outcome of the study 5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial assosiation
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	Hirohisa Kojima
Organization	Japan clinical trial assosiation
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan clinical trial assosiation
Institute
Department

Funding Source
Organization	AHJIKAN CO.,LTD
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 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 18 Day
Anticipated trial start date	2016 Year 11 Month 08 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 08 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028493