UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025246 |
|---|---|
| Receipt number | 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 19:47:01 |
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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
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
maknaganuma@gmail.com
Sponsor or person
Institute
Keio University Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029037
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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