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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022990
Receipt No. 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

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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
Email 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
Email a-mizuki@highway.ne.jp

Sponsor
Institute Keiyu Hospital
Internal Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008835

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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