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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001760
Receipt No. R000001983
Scientific Title The effect of daikenchuto and orengedokuto to the blood flow volume in superior mesenteric artery
Date of disclosure of the study information 2009/03/15
Last modified on 2014/06/03

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Basic information
Public title The effect of daikenchuto and orengedokuto to the blood flow volume in superior mesenteric artery
Acronym The effect of daikenchuto and orengedokuto to the blood flow volume in superior mesenteric artery
Scientific Title The effect of daikenchuto and orengedokuto to the blood flow volume in superior mesenteric artery
Scientific Title:Acronym The effect of daikenchuto and orengedokuto to the blood flow volume in superior mesenteric artery
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to analyze whether daikenchuto or orengedokuto can improve the visceral blood flow or not.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daikenchuto or orengedokuto can increase the blood flow volume of superior mesenteric artery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TSUMURA (TJ-100) Daikenchuto 5g
Interventions/Control_2 TSUMURA (TJ-15) Orengedokuto 2.5g
Interventions/Control_3 Hot water 50ml
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
50 years-old >=
Gender Male
Key inclusion criteria Healthy volunteer (range of age: 20-50 yeas)
Key exclusion criteria The person who has some kind of disease
The person who takes a medicine
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Seki
Organization Tohoku University Graduate School of Medicine
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL 022-717-7185
Email t-seki@m.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Seki
Organization Tohoku University Graduate School of Medicine
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL 022-717-7185
Homepage URL
Email t-seki@m.tohoku.ac.jp

Sponsor
Institute Center for Asian Traditional Medicine
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding 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
2009 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jstage.jst.go.jp/browse/tjem/219/4/_contents/-char/ja/
Number of participants that the trial has enrolled
Results
Superior mesenteric artery blood flow volume was significantly increased between 5 and 90 min after administration of Daikenchuto (p < 0.01) compared to the resting volume. However, there was no significant change in cardiac output after the administration of either agent. The present study indicates that Daikenchuto increases superior mesenteric artery blood flow volume without increasing cardiac output.
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 Completed
Date of protocol fixation
2009 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 06 Day
Last modified on
2014 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001983

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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