UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006689 |
|---|---|
| Receipt number | 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 09:06:46 |
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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
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
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007905
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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