UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of drinking tea containing ginseng on human.
Title of the study (Brief title)	Ginseng tea clinical trial
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to evaluate the efficacy of drinking tea containing ginseng.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluating the cognitive function using HDS-R, Standard verbal paired-associate learning test, and Benton Visual Retention Test after 4 and 12 weeks after the start of the administration.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	ginseng tea 2 packs/day
Interventions/Control_2	Placebo tea 2 packs/day
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) non smokers (2) persons who will generally be judged as healthy (3) persons who have never suffered from asthma (4) persons who have never developed any allegic reaction to medicines, foods, or other substances. (5) Persons who will give written informed consent by themselves.
Key exclusion criteria	(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who changed their habitats of supplements with in 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of Sugar metabolism,lipid metabolism, liver function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Koichiro Ohnuki
Organization	Kindai University
Division name	Department of Biological & Environmental
Address	11-6, Kashiwanomori, Iizuka, Fukuoka
TEL	0948-22-5655
Email	ohnuki@fuk.kindai.ac.jp

Public contact
Name of contact person	Koichiro Ohnuki
Organization	Kindai University
Division name	Department of Biological & Environmental
Address	11-6, Kashiwanomori, Iizuka, Fukuoka
TEL	0948-22-5655
Homepage URL
Email	ohnuki@fuk.kindai.ac.jp

Sponsor
Institute	Kindai University Department of Biological & Environmental Chemistry Faculty of Human-Oriented Science and Engineering
Institute
Department

Funding Source
Organization	Pharmacy Solutions Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2017 Year 10 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 07 Month 27 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	2016 Year 07 Month 26 Day
Last modified on	2018 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026875