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Aug. 31, 2022

April. 04, 2024

jRCTs031220307

Randomized controlled trial of herbal medicine (JPS Gorei Ouge) administration effect related to alcohol metabolism in healthy subjects

Effects of an herbal medicine for the metabolism of alcohol

Namiki Takao

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture

+81-43-226-2984

tnamiki@faculty.chiba-u.jp

Namiki Takao

Medical Mycology Research Center, Chiba University

1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture

+81-43-222-7171

tnamiki@faculty.chiba-u.jp

Recruiting

Aug. 31, 2022

16

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

1. The person who can drink 360ml of Japanese sake and do not show physical deconditioning after the drinking
2. No abnormal findings on health examination, no past histories of diseases such as digestive organ, liver, kidney, and the respiratory organ
3. No serious diseases are begin treated
4. Informed consent by a document is obtained from the person himself

1. The person who cannot regulate the amount or frequency of drinking alcohol
2. The person who regularly takes medicines, such as antiallergic drugs, digestive drugs and any supplement
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 had past histories of health hazards caused by drinking alcohol
5. The person who has an allergy to medicine to be tested
6. The person who the doctor in charge judged that he is not suitable for a participant

20age old over
No limit

Male

status of drunkenness

medication

drunkenness

Blood alcohol concentration after drinking alcohol

Subjective symptoms and breath alcohol concentration after drinking

JPS Pharmaceutical Co Ltd
Applicable
Chiba University Certified Clinical Research Review Board
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture, Chiba, Chiba

+81-43-226-2616

prc-jim@chiba-u.jp
Approval

note

History of Changes

No Publication date
8 April. 04, 2024 (this page) Changes
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1 Aug. 31, 2022 Detail