UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022943 |
|---|---|
| Receipt number | R000026443 |
| Scientific Title | A study on the effect of the intake of fermented ginseng-containing food on stress |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2017/03/01 09:09:25 |
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Basic information
Public title
A study on the effect of the intake of fermented ginseng-containing food on stress
Acronym
A study on the effect of the intake of fermented ginseng-containing food on stress
Scientific Title
A study on the effect of the intake of fermented ginseng-containing food on stress
Scientific Title:Acronym
A study on the effect of the intake of fermented ginseng-containing food on stress
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the improvement effects of ingestion of fermented ginseng-containing food for 8 consecutive weeks on stress, quality of the sleep, fatigue, and stress biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress:POMS2-AS
Sleep:AIS, PSQI-j
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
Ingestion of test food containing fermented ginseng for 8 consecutive weeks
Interventions/Control_2
Ingestion of placebo without fermented ginseng for 8 consecutive 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Male and female workers from 30 to 60 years old
2) POMS2-AS FI T score is 50 and more, and VA T score is 50 and less
Key exclusion criteria
1)Subjects who routinely use food or medicine containing of ginsenosides
2)Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress
3)Subjects who wake after sleep onset for nocturia twice and more than twice a week
4)Night and day shift worker or manual laborer
5)Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor
6)Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome
7)Subjects diagnosed with chronic fatigue syndrome
8)Subjects who were under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease)
9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires
10)Subjects having possibilities for emerging allergy related to the study
11)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
12)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
13)Subjects who are planned to become pregnant after informed consent for the current study
or are pregnant or lactating
14)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Han Jong Pyo |
Organization
Naturetech Co., Ltd.
Division name
R&D Center
Zip code
Address
29-8, Yongjeong-Gil, Chopyeong-Myeon, Jincheon-Gun, Chungbuk, Korea 365-850
TEL
+82-43-530-7944
pyobass@naturetech.co.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsushi Yamamoto |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
e.yamamoto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Naturetech Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026443
