UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020981 |
|---|---|
| Receipt number | R000024099 |
| Scientific Title | Study of Hangeshasinto and Rikkunshito for Irritable bowel syndrome |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2020/08/04 13:45:14 |
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Basic information
Public title
Study of Hangeshasinto and Rikkunshito for Irritable bowel syndrome
Acronym
Kampo medicine for Irritable bowel syndrome
Scientific Title
Study of Hangeshasinto and Rikkunshito for Irritable bowel syndrome
Scientific Title:Acronym
Kampo medicine for Irritable bowel syndrome
Region
| Japan |
Condition
Condition
Irritable bowel syndrome (IBS) with diarrhea
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effect of Hangeshashinto and Rikkunshito for IBS with diarrhea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of symptom of IBS at the end of 28-day drug intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hangesyashinto 5.0g/day, daily twice, for 28 days
Rikkunshito 5.0g/day, daily twice, for 28 days
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Irritable bowel syndrome diarrhea type
Not frail
Key exclusion criteria
Tumor, inflammatory bowel disease
Patients has took laxative, antidiarrheal agents, or probiotics within 1 week before the study
Patient has took antibiotics, anti-inflammatory agents, or steroid within 6 week before the study
Patient is under medication with anticholinergic drugs, antimuscarinic drugs, proton pump inhibitor, or minor tranquilizer
Patient has past history of bowel operation (operation of appendicitis is applicable)
hypokalemia (K under 3.5mEq/l), liver dysfunction (AST over twice the reference value)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takayama |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL
0227177507
takayama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwabara |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL
0227177507
Homepage URL
akiko.kuwabara.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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 | 02 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | 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 | 02 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024099
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
