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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027334
Receipt No. R000031068
Scientific Title Effects of Kampo medicine for metabolism of alcohol
Date of disclosure of the study information 2017/05/22
Last modified on 2019/11/19

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Basic information
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
Condition status of drunkenness
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
Primary outcomes serum concentration of alcohol,
balance test, after drinking
Key secondary outcomes

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Japan Society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2017 Year 05 Month 22 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 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

Progress
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
Other related information

Management information
Registered date
2017 Year 05 Month 13 Day
Last modified on
2019 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031068

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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