UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study investigating the safety and efficacy of daikenchuto for the treatment of abdominal bloating.
Title of the study (Brief title)	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	Mika Yuki
Organization	Izumo-City General Medical Center
Division name	Division of Internal Medicine
Address	613 Nadabun-cho, Izumo City, Shimane Prefecture
TEL	0853-63-5111
Email	yuuki-mika@izumo-hospital.jp

Public contact
Name of contact person	Mika Yuki
Organization	Izumo-City General Medical Center
Division name	Division of Internal Medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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