UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Is it effective Burdock tea to prevent of reattack of colonoc diverticulitis, diverticuler bleeding.
Title of the study (Brief title)	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	Akira Mizuki
Organization	Keiyu Hospital
Division name	Internal Medicine
Address	3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL	045-221-8181
Email	a-mizuki@highway.ne.jp

Public contact
Name of contact person	Akira Mizuki
Organization	Keiyu Hospital
Division name	Internal medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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