UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016442 |
|---|---|
| Receipt number | R000019095 |
| Scientific Title | A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating. |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2016/11/29 19:30:10 |
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Basic information
Public title
A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating.
Acronym
A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating.
Scientific Title
A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating.
Scientific Title:Acronym
A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating.
Region
| Japan |
Condition
Condition
Patients with abdominal bloating
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of daikenchuto for the treatment of abdominal bloating in patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-reported abdominal bloating rating
Key secondary outcomes
Self-reported satisfaction rating with treatment
SF-8
GSRS
Bristol stool scale
Abdominal girth
Rate of Sympathetic
/parasympathetic
Salivary amylase activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of Daikenchuto 15.0g/day for 4weeks.
Interventions/Control_2
Oral administration of Biofermin 3T/day for 4weeks.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Self-reported abdominal bloating rating >= 4
20 <= years old <= 84
Male and female
Outpatients
Provides written informed consent
Key exclusion criteria
Patients receiving daikenchuto or other Japanese traditional herbal medicine within 4 weeks before enrolled in this study
If not stable doses of the follow medications are taken for at least 2 weeks before enrolled to this study: acid suppressant, prokinetics, calcium polycarbophil, anticholinergic drug, laxative, antidepressant, anti-anxiety agent.
Patients with organic lesion like cancer.
Patients with serious coexisting disease (e.g. Hepatic, renal, cardiac, hematological, or metabolic disorder).
Lactating or pregnant mother or women who wish to become pregnant during the study period.
Determined not applicable for this study by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Yuki |
Organization
Izumo-City General Medical Center
Division name
Division of Internal Medicine
Zip code
Address
613 Nadabun-cho, Izumo City, Shimane Prefecture
TEL
0853-63-5111
yuuki-mika@izumo-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Yuki |
Organization
Izumo-City General Medical Center
Division name
Division of Internal Medicine
Zip code
Address
Izumo City, Shimane Prefecture
TEL
0853-63-5111
Homepage URL
yuuki-mika@izumo-hospital.jp
Sponsor or person
Institute
Izumo-City General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 02 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
