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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016442
Receipt No. 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

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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
Email 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
Email yuuki-mika@izumo-hospital.jp

Sponsor
Institute Izumo-City General Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019095

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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