status of drunkenness
Conditions
Interventions
after thirty minuites of administering 3.75g of orengedokuto extract, drinking 180ml of Japanese sake, single session
after thirty minuites of administering 3.75g of lactose(placebo), drinking 180ml
Sponsors
Department of Kampo and Integrative Medicine Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum concentration of alcohol, balance test, after drinking | — |
Countries
Japan
Contacts
Public ContactTakehiro Numata
Tohoku University Graduate School of Medicine Department of Kampo and Integrative Medicine
Outcome results
None listed