UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of daiobotampito in the treatment of acute diverticulitis of colon: a single-center open-label randomized controlled trial
Title of the study (Brief title)	Trial about efficacy of daiobotampito in the treatment of acute diverticulitis
Region	Japan

Condition
Condition	diverticulitis of colon
Classification by specialty	Gastroenterology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy of daiobotampito in the treatment of diverticulitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Visual analogue scale (VAS) of abdominal pain on day 3
Key secondary outcomes	VAS of abdominal pain other than day 3 Day on which VAS of pain becomes equal to or less than 50 mm Frequency of stool Frequency of ingravescence of diverticulitis, which patients need operation Frequency of adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients are treated with fasting, antibacterial agents, and 7.5g per day of daiobotampito extract (Tsumura co.) for 10 days or not.
Interventions/Control_2	Patients are treated with fasting, antibacterial agents. They are not treated with daiobotampito extract.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with diverticulitis who have strong pain (VAS > 50mm)
Key exclusion criteria	High probability to perforate. Diarrhea or soft stool. Chronic appetite loss, abdominal pain or diarrhea. Too friable. Insulin use. Immuno-compromised host. Pregnant or puerperal. Kidney disease (eGFR < 20 ml/min/1.73m^2). Allergy to daiobotampito. Experience to join in this trial before. Doctor's diagnosis as inappropriate.
Target sample size	60

Research contact person
Name of lead principal investigator	Nakazawa, Atsushi
Organization	Tokyo Saiseikai Central Hospital
Division name	Gastrointestinal Medcine
Address	Mita 1-4-17, Minato-ku, Tokyo, Japan 108-0073
TEL	03-3451-8211
Email	anakaza@b-star.jp

Public contact
Name of contact person	Koike, Hiroshi
Organization	Tokyo Saiseikai Central Hospital
Division name	General Internal Medcine
Address	Mita 1-4-17, Minato-ku, Tokyo, Japan 108-0073
TEL	03-3451-8211
Homepage URL
Email	koike-h@umin.ac.jp

Sponsor
Institute	Gastrointestinal Medcine, Tokyo Saiseikai Central Hospital
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Center for Kampo Medicine, Keio University School of Medicine
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 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 02 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025929