UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014995 |
|---|---|
| Receipt number | 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 16:33:20 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
