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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025246
Receipt No. R000029037
Scientific Title Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Date of disclosure of the study information 2016/12/13
Last modified on 2018/02/19

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Basic information
Public title Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Acronym Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Scientific Title Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.
Scientific Title:Acronym 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
1st name
Middle name
Last name Takanori Kanai
Organization Keio University
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinano-machi, Shinjyu-ku , Tokyo
TEL 03-3353-1211
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Naganuma
Organization Keio University
Division name Gastroenterology and Hepatology
Zip code
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)

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 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
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

Other
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

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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