臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 31, 2022
Last modified on	April. 04, 2024
Trial ID	jRCTs031220307

Scientific Title	Randomized controlled trial of herbal medicine (JPS Gorei Ouge) administration effect related to alcohol metabolism in healthy subjects
Public Title	Effects of an herbal medicine for the metabolism of alcohol

Contact for Scientific Queries	Name	Namiki Takao
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture
	Telephone	+81-43-226-2984
	E-mail	tnamiki@faculty.chiba-u.jp
Contact for Public Queries	Name	Namiki Takao
	Affiliation	Medical Mycology Research Center, Chiba University
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture
	Telephone	+81-43-222-7171
	E-mail	tnamiki@faculty.chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 31, 2022
Actual date of first enrollment
Target sample size		16
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	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
	Exclusion Criteria	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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		status of drunkenness
Intervention(s)		medication
Health Condition(s) Keyword		drunkenness
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Blood alcohol concentration after drinking alcohol
Secondary Outcome(s)		Subjective symptoms and breath alcohol concentration after drinking

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	JPS Pharmaceutical Co Ltd
Secondary Sponsor	Applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture, Chiba, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	June. 27, 2022

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	note

History of Changes

No	Publication date
8	April. 04, 2024	(this page)	Changes
7	Mar. 27, 2024	Detail	Changes
6	Mar. 27, 2024	Detail	Changes
5	June. 15, 2023	Detail	Changes
4	Feb. 28, 2023	Detail	Changes
3	Sept. 29, 2022	Detail	Changes
2	Sept. 29, 2022	Detail	Changes
1	Aug. 31, 2022	Detail

List of change history