UMIN-CTR Clinical Trial

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