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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014995
Receipt No. R000017441
Scientific Title A randomized controlled trial for effect of alcohol metabolism.
Date of disclosure of the study information 2014/08/29
Last modified on 2014/08/29

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Basic information
Public title A randomized controlled trial for effect of alcohol metabolism.
Acronym A randomized controlled trial for effect of alcohol metabolism.
Scientific Title A randomized controlled trial for effect of alcohol metabolism.
Scientific Title:Acronym A randomized controlled trial for effect of alcohol metabolism.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the product containing curcumin to alcohol metabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood alcohol concentration
Blood acetaldehyde concentration
Key secondary outcomes Physical examinations
Blood test
Urine test
Breath alcohol concentration
Questionnaires(bodily sensation)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Sequence:Turmeric containing supplements -wash out-placebo
Interventions/Control_2 Sequence:placebo-wash out-Turmeric containing supplements
Interventions/Control_3
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1)Subjects who is male and 20 years of age or older at the time of informed consent.
2)Subjects who is drinking possible.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1)Subjects who have previous medical history of drug and/or food allergy.

2)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., diabetes, digestive organ, liver, pancreas, heart and/or kidney).

3)Subjects who have been enrolled in the other clinical trials within about last 1 month.

4)Subjects who predicted gluttony and irregular eating habits by the pre-questionnaire and doctor's questions.

5)Subjects who constantly use supplements and/or functional foods affecting alcohol metabolism.(e.g. Turmeric-containing foods and beverages)

6)Subjects who can't drink alcohol.

7)Subjects who excessive alcohol intake.

8)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.

9)Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study.

10)Subjects who collected blood amount of blood sampling over 1200 mL within the last twelve months prior to the current study and this clinical trial's blood sampling.

11)Subjects who take medicines and plan to take new health foods.

12)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa SAKANO
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5927-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto ICHINOHE
Organization CPCC Company Limited
Division name Plan sales department
Zip code
Address 2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Omnica 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
Address
Tel
Email

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
2014 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 13 Day
Last follow-up date
2014 Year 02 Month 27 Day
Date of closure to data entry
2014 Year 03 Month 10 Day
Date trial data considered complete
2014 Year 03 Month 20 Day
Date analysis concluded
2014 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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