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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042849
Receipt No. R000048884
Scientific Title A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Anti-Stress Efficacy of Complementary-Alternative Medicine in Healthy subjects
Date of disclosure of the study information 2021/01/01
Last modified on 2020/12/25

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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
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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 01 Day
Date of IRB
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
2020 Year 12 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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