UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Panax ginseng-containing tea on cognitive performance in adolescence
Title of the study (Brief title)	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	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	744 Motooka Nishi-ku Fukuoka-shi
TEL	092-802-4675
Email	shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	744 Motooka Nishi-ku Fukuoka-shi
TEL	092-802-4675
Homepage URL
Email	shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute	Faculty of Agriculture, Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038772