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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006689
Receipt No. R000007905
Scientific Title Study investigating the effect of a burdock tea powder on chronic constipation
Date of disclosure of the study information 2011/11/08
Last modified on 2013/03/26

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Basic information
Public title Study investigating the effect of a burdock tea powder on chronic constipation
Acronym Study investigating the effect of a burdock tea powder on chronic constipation
Scientific Title Study investigating the effect of a burdock tea powder on chronic constipation
Scientific Title:Acronym Study investigating the effect of a burdock tea powder on chronic constipation
Region
Japan

Condition
Condition chronic constipation
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the effects of roasted burdock powder on the bowel habits of subjects with chronic constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bowel frequency, stool consistency, the numbers of radiopaque markers remaining in the colon
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
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 The subjects take 2 kinds of supplementary diets for 2 weeks each, with a 1-week washout period between them. The placebo supplementary diet(control) is freeze-dried miso soup and the experimental diet is freeze-dried miso soup supplemented with 10 g of burdock powder. The supplementary diets are taken twice daily, at breakfast and dinner, with their usual diet for 2 weeks. Thus, the daily administration of burdock powder during the administration period is 20 g. The order of the supplementary diets for each subject is randomly chosen.
Interventions/Control_2 The subjects take 2 kinds of supplementary diets for 2 weeks each, with a 1-week washout period between them. The placebo supplementary diet(control) is freeze-dried miso soup and the experimental diet is freeze-dried miso soup supplemented with 10 g of burdock powder. The supplementary diets are taken twice daily, at breakfast and dinner, with their usual diet for 2 weeks. Thus, the daily administration of burdock powder during the administration period is 20 g. The order of the supplementary diets for each subject is randomly chosen.
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 Femals who have less than twice weekly bowel habits
Key exclusion criteria Pregnant, possibly pregnant, and lactating subjects are excluded, as are those, taking laxatives or prokinetics on an on-demand basis and subjects with drug induced constipation.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shimane University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
Homepage URL
Email

Sponsor
Institute Shimane University School of Medicine
Institute
Department

Funding Source
Organization Shimane University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Ahjikan Co., LTD
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
2011 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Seven patients were analyzed. There were no significant differences regarding mean bowel frequency and stool consistency between the burdock powder administration and control periods, though burdock powder showed a tendency to increase bowel frequency and make stools softer. The numbers of radiopaque markers remaining in the colon at the end of the control and burdock powder periods were not different. No adverse event related to consumption of roasted burdock powder was observed. 
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
2010 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 08 Day
Last modified on
2013 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007905

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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