UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on the Alleviation of the Symptom of a Hangover on the Next Day of Drinking
Acronym	A Study on the Effect of Food Containing Plant Extract on the Alleviation of the Symptom of a Hangover on the Next Day of Drinking
Scientific Title	A Study on the Effect of Food Containing Plant Extract on the Alleviation of the Symptom of a Hangover on the Next Day of Drinking
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on the Alleviation of the Symptom of a Hangover on the Next Day of Drinking
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of food containing plant extract on the symptom of a hangover
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaires on a hangover
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Food containing low-dose plant extract, single ingestion
Interventions/Control_2	Food containing high-dose plant extract, single ingestion
Interventions/Control_3	Food not containing plant extract, single ingestion
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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	(1) Males aged 30 to 59 years-old. (2) Subjects who are healthy and are not suffered from chronic disease. (3) Subjects who can take alcohol (ND type or NN type in the alcohol patch test), and are likely to have a hangover the next day. (4) Subjects who can make self-judgment and are voluntarily giving written informed consent. (5) Subjects who can have an examination on a designated check day. (6) Subjects who are judged as suitable for the current study by the investigator.
Key exclusion criteria	(1) Subjects with DD type in the alcohol patch test. (2) Subjects who have never had a hangover. (3) Subjects who have excessive alcohol intake more than 60 g/day of pure alcohol equivalent. (4) Subjects who contract disease and are under treatment. (5) Subjects who have a history of and/or contract serious diseases (eg, hyperlipidemia, high blood pressure, diabetes, psychiatric disease, sleeping disorder ). (6) Subjects who used a drug to treat a disease in the past 1 month (except temporal usage for headache and cold). (7) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, heart disease, lung disease, blood disease). (8) Subjects who have a history and/or contract digestive disease (except disease of an appendix). (9) Subjects whose BMI are under 18.5 or 30 or more. (10) Subjects with serious anemia. (11) Subjects who have allergic reaction to ingredients of test foods and other foods or drugs. (12) Subjects with possible changes of life style, such as a long-term travel and a late-night shift, during test periods. (13) Subjects who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve liver function (curcumin, clam extract, liver extract, etc.) in the past 3 months and/or are planning to use those foods during test periods. (14) Subjects who have difficulty in taking meals (dinner and lunch on the inspection day). (15) Subjects who are participating and/or had participated in other clinical studies within the last three months prior to the current study. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Kondo
Organization	Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name	Director
Zip code	169-0072
Address	3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL	+81-3-6233-8583
Email	h.kondo@meiseikai-cl.com

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.jp

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	2020 Year 07 Month 05 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046812
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49060/965
Number of participants that the trial has enrolled	42
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2021 Year 10 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 30 to 59 years old.
Participant flow	Enrolled(n=42) Completed(n=39) Analysed(n=34)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	Questionnaires on a hangover
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 06 Month 23 Day
Date of IRB	2020 Year 06 Month 24 Day
Anticipated trial start date	2020 Year 07 Month 06 Day
Last follow-up date	2020 Year 08 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 03 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046812