UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022990 |
|---|---|
| Receipt number | R000008835 |
| Scientific Title | Is it effective Burdock tea to prevent of reattack of colonoc diverticulitis, diverticuler bleeding. |
| Date of disclosure of the study information | 2016/07/02 |
| Last modified on | 2018/02/26 11:41:27 |
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Basic information
Public title
Is it effective Burdock tea to prevent of reattack of colonoc diverticulitis, diverticuler bleeding.
Acronym
Burdock tea prevents of reattack of colonoc diverticulitis, diverticuler bleeding?
Scientific Title
Is it effective Burdock tea to prevent of reattack of colonoc diverticulitis, diverticuler bleeding.
Scientific Title:Acronym
Burdock tea prevents of reattack of colonoc diverticulitis, diverticuler bleeding?
Region
| Japan |
Condition
Condition
acute colonic diverticulitis, diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the usefulness of the burdock tea in prevention to recurrence of acute colonic diverticulitis and diverticular bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of recurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
burdock tea
Interventions/Control_2
control
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
acute colonic diverticulitis, colonic divericular bleeding
Key exclusion criteria
sever cmobidity
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Mizuki |
Organization
Keiyu Hospital
Division name
Internal Medicine
Zip code
Address
3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL
045-221-8181
a-mizuki@highway.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Mizuki |
Organization
Keiyu Hospital
Division name
Internal medicine
Zip code
Address
3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL
045-221-8181
Homepage URL
a-mizuki@highway.ne.jp
Sponsor or person
Institute
Keiyu Hospital
Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Keiyu Hospital
Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2016 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008835
