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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036274
Receipt No. 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

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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
Email 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
Email chihiro@inm.u-toyama.ac.jp

Sponsor
Institute Division of Neuromedical Science, Institute of Natural Medicine, University of Toyama
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041315

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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