UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042849 |
|---|---|
| Receipt number | 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 | 2022/03/07 16:26:54 |
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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
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
stress-relief@ml.huhs.ac.jp
Sponsor or person
Institute
Hyogo University of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048884
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