UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Title of the study (Brief title)	Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Region	Japan

Condition
Condition	chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we aim to assess safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome after 24weeks
Key secondary outcomes	efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome (endoscopic evaluation, clinical symptoms, Hb levels and serum Alb levels after 8 and 24 weeks)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	indigo naturalis 2g/day for oral administration is be administered daily in 2 divided doses during 8weeks.
Interventions/Control_2
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The patients were diagnosed chronic enteropathy associated with SLCO2A1 gene or Cronkhite-Canada syndrome. 2)The patients were 20~69 years old. 3)The patients who were obtained the consent. in this study.
Key exclusion criteria	The patients who meet the following criteria are excluded. 1 The patients have stricture of the digestive tract. 2 The patients plans to undergo surgery. 3 The patients have severe infection. 4 The patients have severe heart failure. 5 The patients have serum Creatinine above 2. 6 The patients have T.Bil above 2.0, AST above 50, or ALT above 50. 7 The patients have malignancy or past history of malignancy. 8 The patients have neuropsychiatric disorder. 9 Women who are or may be pregnant, nursing women and woman who desire to bear children. 10 Inappropriate patients by doctor's judgement. 11 The patients who received other traditional chinese medicine inside 2 weeks.
Target sample size	6

Research contact person
Name of lead principal investigator	Takanori Kanai
Organization	Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Email	takagast@z2.keio.jp

Public contact
Name of contact person	Makoto Naganuma
Organization	Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Homepage URL
Email	maknaganuma@gmail.com

Sponsor
Institute	Keio University Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Self founding
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 12 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 13 Day
Anticipated trial start date	2016 Year 12 Month 13 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 12 Month 13 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029037