UMIN-CTR Clinical Trial

Public title

Effects of Kampo medicine for metabolism of alcohol

Acronym

Effects of orengedokuto for metabolism of alcohol

Scientific Title

Effects of Kampo medicine for metabolism of alcohol

Scientific Title:Acronym

Effects of orengedokuto for metabolism of alcohol

Region

Japan

Condition

status of drunkenness

Classification by specialty

Hepato-biliary-pancreatic medicine

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To investigate the efficacy for alcoholic metabolism of orengedokuto extract (TJ-15) in treating drunken subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

serum concentration of alcohol,
balance test, after drinking

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Food

Interventions/Control_1

after thirty minuites of administering 3.75g of orengedokuto extract, drinking 180ml of Japanese sake, single session

Interventions/Control_2

after thirty minuites of administering 3.75g of lactose(placebo), drinking 180ml of Japanese sake, single session

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male

Key inclusion criteria

The person who filled the following 6 criteria can be registered as a participant.
1. Healthy male, range: 20 - 60 years
2. The person who can drink 360ml of Japanese sake and do not show physical deconditioning after the drinking
3. The person who drink alcohol 360ml of Japanese sake and do not show physical deconditioning after the drinking
4. No abnormal findings on health examination, no past histories of diseases such as digestive organ, liver, kidney and the respiratory organ
5. No diseases which is being treated
6. Informed consent by a document is obtained from the person himself.

Key exclusion criteria

The person who filled at least one of the following 11 criteria cannot be registered as a participant.
1. The person who cannot regulate amount or frequency of drinking alcohol
2. The person who take internal medicine regularly, such as antiallergic drugs
3. The person who has experiences of physical deconditioning after the small amount of drinking alcohol (e.g. 500ml beer or 180ml Japanese sake)
4. The person who have past histories of health hazard caused by drinking alcohol
5. The person who showed a liver function failure (AST or ALT: over standard value) by a blood test, or a positive reaction by an alcoholic patch test, in a preliminary screening test
6. The person who was revealed that he has homozygous lost activation type of acetaldehyde dehydrogenase type 2 by the test of gene
7. The person who has an allergy to Kampo medicine including Scutellariae Radix, Coptidis Rhizoma, Phelodendri Cortex and Gardeniae Fructus
8. Past history of lactose intolerance
9. Past history of alcohol dependence
10. The person who the doctor in charge judged that he is not suitable for a participant

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takehiro Numata

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Kampo and Integrative Medicine

Zip code

Address

1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan

TEL

022-717-7587

Email

takehiro.numata.c2@tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Takehiro Numata

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Kampo and Integrative Medicine

Zip code

Address

1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan

TEL

022-717-7587

Homepage URL

Email

takehiro.numata.c2@tohoku.ac.jp

Institute

Department of Kampo and Integrative Medicine
Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

04

Month

25

Day

Date of IRB

2019

Year

07

Month

11

Day

Anticipated trial start date

2017

Year

06

Month

01

Day

Last follow-up date

2019

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

13

Day

Last modified on

2019

Year

11

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031068