UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034367 |
|---|---|
| Receipt number | R000038772 |
| Scientific Title | Effects of Panax ginseng-containing tea on cognitive performance in adolescence |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2018/10/03 15:20:35 |
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Basic information
Public title
Effects of Panax ginseng-containing tea on cognitive performance in adolescence
Acronym
Effects of Panax ginseng-containing tea on cognitive performance
Scientific Title
Effects of Panax ginseng-containing tea on cognitive performance in adolescence
Scientific Title:Acronym
Effects of Panax ginseng-containing tea on cognitive performance
Region
| Japan |
Condition
Condition
Child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of containing-ginseng tea on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Krupeline trainer
Benton visual test
TK system Tanaka AB style intelligence test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Panax ginseng-containg tea
Interventions/Control_2
placebo
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
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy
2) Persons who can consume powdered tea every day during the period
3) Those who can visit the measurement site twice in total for measurement
Key exclusion criteria
1) continuously use health foods, quasi-drugs or medicines highlighting or emphasizing effectiveness similar to or related to the effect examined in this study 2) At the time of acquiring consent, those who are receiving treatment (hormone replacement therapy, medication therapy, exercise therapy, diet therapy, etc.) at medical institutions or the like for the treatment or prevention of diseases, 3) the history of serious diseases or psychiatric diseases of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory organ, respiratory organs, endocrine system, immune system, nervous system 4) Persons who are at risk of developing allergy to food 5) participating in other human tests (tests on humans using foods, medicines, quasi-drugs, medical devices, etc.) within the past 4 weeks, or during the period when this study is scheduled to be performed Person who is planning to participate in other human exams 6) Those who judge that the investigator is inappropriate for participating in the examinations.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniyoshi Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
Address
744 Motooka Nishi-ku Fukuoka-shi
TEL
092-802-4675
shimizu@agr.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniyoshi Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
Address
744 Motooka Nishi-ku Fukuoka-shi
TEL
092-802-4675
Homepage URL
shimizu@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Agriculture, Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Humanity-Oriented Science and Engineering, Kindai University
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
| 2022 | Year | 10 | Month | 01 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 03 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038772
