UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036274 |
|---|---|
| Receipt number | R000041315 |
| Scientific Title | Effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/03/12 10:41:04 |
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Basic information
Public title
Effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults
Acronym
Effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults
Scientific Title
Effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults
Scientific Title:Acronym
Effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate effects of mixed extracts of Drynaria fortunei rhizomes and Eleutherococus senticosus leaves on cognitive functions and stress in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RBANS-J for cognition, Public Health Research Foundation Stress Check List Short Form for anti-stress, before and 12 weeks after the intake.
Key secondary outcomes
JART, MMSE-J for cognition, before and 12 weeks after the intake.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Tretament test drug: Intake of capsules containing two extracts of Drynaria fortunei rhizomes (20 mg/capsule) and Eleutherococus senticosus leavesas (200 mg/capsule), three capsules per day, for 12 weeks.
Interventions/Control_2
Treatment placebo:Intake of capsules without two etracts, three capsules per day, for 12 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy human psychologically and physically between age 40 to 80 years old, who volunteers to attend this clinical study.
Key exclusion criteria
Subjects under 20 years old, pregnant or lactating. Subjects having mental illnesses. Subjects judged being inappropriate by other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Tohda |
Organization
University of Toyama
Division name
Division of Neuromedical Science, Institute of Natural Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, 930-0194, JAPAN
TEL
076-434-7646
chihiro@inm.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Tohda |
Organization
University of Toyama
Division name
Division of Neuromedical Science, Institute of Natural Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, 930-0194, JAPAN
TEL
076-434-7646
Homepage URL
chihiro@inm.u-toyama.ac.jp
Sponsor or person
Institute
Division of Neuromedical Science, Institute of Natural Medicine, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
IRB center, Sugitani campus, University of Toyama
Address
2630 Sugitani, Toyama, 930-0194, JAPAN
Tel
076-434-7145
yuka@adm.u-toyama.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
国立大学法人 富山大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
33
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
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 03 | Month | 22 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041315
