UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052295 |
|---|---|
| Receipt number | R000059705 |
| Scientific Title | The Effects of Acanthopanax senticosus on Anxiety, Motivation to Learn, Sleep Status, and Fatigue Associated with Learning Status in Students |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2023/09/25 11:56:41 |
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Basic information
Public title
The Effects of Acanthopanax senticosus on Anxiety, Motivation to Learn, Sleep Status, and Fatigue Associated with Learning Status in Students
Acronym
The Effects of Acanthopanax senticosus on Anxiety, Motivation to Learn, Sleep Status, and Fatigue Associated with Learning Status in Students
Scientific Title
The Effects of Acanthopanax senticosus on Anxiety, Motivation to Learn, Sleep Status, and Fatigue Associated with Learning Status in Students
Scientific Title:Acronym
The Effects of Acanthopanax senticosus on Anxiety, Motivation to Learn, Sleep Status, and Fatigue Associated with Learning Status in Students
Region
| Japan |
Condition
Condition
male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Acanthopanax senticosus is beneficial for students in terms of motivation to learn and health maintenance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Questionnaires for subjective
2.General Self-efficacy Scale (GSES)
3.OSA sleep inventory
4.STAI
Key secondary outcomes
1.salivary amylase
2.salivary cortisol
3.Autonomic activity
4.Objective sleep quality (measured using actigrapgh)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-weeks intake of the test food
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healty Subjects.
2.Subjects who are males or females and are aged 18 or older.
3.Subjects who have provided written consent for participation in the study.
Key exclusion criteria
1.The persons who have taken Acanthopanax Senticosus and are not off it for more than 3 months.
2.Those who regularly use health foods that may affect the study.
3.Allergy to Acanthopanax Senticosus.
4.Subject who is not currently receiving treatment or medication.
5.Subject with current or history of alcohol dependence.
6.Those who are participating in other clinical studies.
7.Subject with severe diseases such as hepatic disorder, kidney disorder, heart disease.
8.Subject who have hepatitis.
9.Severe anemia.
10.Subjects with systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 90 mmHg.
11.Other cases that the principal investigator and subinvestigators deem inappropriate as research subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fujikawa |
| Middle name | |
| Last name | Takahiko |
Organization
Suzuka University of Medical Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
513-8670
Address
3500-3, Minamitamagaki, Suzuka-city, Mie, 513-8670, JAPAN
TEL
059-340-0550
t-fuji@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Fujishima |
| Middle name | |
| Last name | Masaki |
Organization
Sun Chlorella Corp.
Division name
Production & Development Department Research & Development Group
Zip code
600-8177
Address
369 Osaka-cho, karasumi-dori Gojo-sagaru, shimogyo-ku, Kyoto
TEL
075-288-3010
Homepage URL
mfujishima@sunchlorella.co.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suzuka University of Medical Science
Address
3500-3, Minamitamagaki, Suzuka-city, Mie, 513-8670, JAPAN
Tel
059-340-0550
t-fuji@suzuka-u.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
鈴鹿医療科学大学 / Suzuka University of Medical Science
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 25 | 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
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059705
