UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Anti-Stress Efficacy of Complementary-Alternative Medicine in Healthy subjects
Acronym	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Anti-Stress Efficacy of Complementary-Alternative Medicine in Healthy subjects
Scientific Title	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Anti-Stress Efficacy of Complementary-Alternative Medicine in Healthy subjects
Scientific Title:Acronym	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Anti-Stress Efficacy of Complementary-Alternative Medicine in Healthy subjects
Region	Japan

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

Objectives
Narrative objectives1	To examine the anti-stress effects of food material NBC_H1.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of oral administration (single administration or 2 weeks continuous administration) of food material NBC_H1 on the following index: Blood pressure, Heart rate, Score of amylase in saliva, Score of cortisol in saliva, Score of D2-concentration Test(speed of task, rate of error, omission error, commission error)
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	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product NBC_H1 (4 pills/day; 2 weeks).
Interventions/Control_2	Oral ingestion of the placebo products NBC_H1P (4 pills/day; 2 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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subject agreeing to participate in the study with signing a written informed consent 2) Males and females whose age of 20-65 years at signing informed consent. 3)Subjects who are healthy and are not have chronic diseases
Key exclusion criteria	1)Subjects who have a history of cardiac diseases like arrhythmia. 2)Subjects who have a history of allergic symptoms by the ginseng. 3)Subjects who have a history of allergic symptoms by food. 4)Subjects who have a history of mental disease. 5)Subjects who have a history of using antipsychotic drug. 6)Subjects who use a drug to treat a disease. 7)Subjects who ingest supplements or energy drinks include ginseng. 8)Subjects who can't stop use of health food such as supplements, energy drinks. 9)Subjects who are a color-blind person. 10)Subjects who are a smoker. 11)Subjects who have abnormal score of amylase and cortisol in saliva, blood pressure and heart rate. 12)Subjects who suffered pain usually. 13)Subjects who participated in other clinical studies. 14)Subjects who take foods or dinks which are not provided from noon to fifteen on the day of study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name YI Middle name Last name DAI
Organization	Hyogo University of Health Sciences
Division name	School of Pharmacy
Zip code	650-8530
Address	1-3-6 Minatojima Chuo-ku, Kobe, Hyogo
TEL	078-304-3147
Email	ydai@huhs.ac.jp

Public contact
Name of contact person	1st name YOKO Middle name Last name KOGURE
Organization	Hyogo University of Health Scineces
Division name	School of Pharmacy
Zip code	650-8530
Address	1-3-6 Minatojima Chuo-ku, Kobe, Hyogo
TEL	078-304-3166
Homepage URL
Email	stress-relief@ml.huhs.ac.jp

Sponsor
Institute	Hyogo University of Health Sciences
Institute
Department

Funding Source
Organization	Nagase Beauty Care Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Hyogo University of Health Sciences

IRB Contact (For public release)
Organization	Research Ethics Review Committee at Hyogo University of Health Sciences
Address	1-3-6 Minatojima Chuo-ku, Kobe, Hyogo
Tel	078-304-3022
Email	kenkyu-shien@huhs.ac.jp

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	2021 Year 01 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	40
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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 09 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 04 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 25 Day
Last modified on	2022 Year 03 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048884