UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040996 |
|---|---|
| Receipt number | R000046812 |
| 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 |
| Date of disclosure of the study information | 2020/07/05 |
| Last modified on | 2021/10/26 14:32:53 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046812
