UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023291 |
|---|---|
| Receipt number | R000026849 |
| Scientific Title | A clinical trial about the safety of black ginger extract supplementation |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2017/01/19 18:14:01 |
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Basic information
Public title
A clinical trial about the safety of black ginger extract supplementation
Acronym
A clinical trial about the safety of black ginger extract supplementation
Scientific Title
A clinical trial about the safety of black ginger extract supplementation
Scientific Title:Acronym
A clinical trial about the safety of black ginger extract supplementation
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety for oral intake of black ginger extract
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, pulse, blood test, urinalysis, questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
500mg/day black ginger extract supplementation (4 weeks)
Interventions/Control_2
500mg/day placebo supplementation (4 weeks)
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 and Female
Key inclusion criteria
Healthy subjects, male and female, who are 20 years of age or over
Key exclusion criteria
1) Subjects in medication, or who have anamnesis with serious disease that require medication
2) Subjects with chronic disease of asthma
3) Subjects who are allergic to the test sample
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Shimoda |
Organization
ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name
R & D Center
Zip code
Address
1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL
0586865141
kaihatsu@mri.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Toda |
Organization
ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name
Food Development Dept. R & D Center
Zip code
Address
1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL
0586865141
Homepage URL
kaihatsu@mri.biglobe.ne.jp
Sponsor or person
Institute
ORYZA OIL & FAT CHEMICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ORYZA OIL & FAT CHEMICAL 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
| 2016 | Year | 12 | Month | 31 | 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
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 07 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026849
