UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001760
Receipt number 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 08:41:19

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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 or person

Institute

Center for Asian Traditional Medicine

Institute

Department

Personal name



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

Value
https://center6.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