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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043494
Receipt No. R000049662
Scientific Title Efficacy of the mixture of Gingko biloba extract with Sesame extract and Turmeric oil on cognitive function in healthy adults: a 24 weeks, randomized double-blind, placebo-controlled trial
Date of disclosure of the study information 2021/05/01
Last modified on 2021/03/02

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Basic information
Public title Association of the simultaneous administration of Gingko biloba extract and absorption promoting agent with cognitive function
Acronym Association of Gingko biloba extract with cognitive function
Scientific Title Efficacy of the mixture of Gingko biloba extract with Sesame extract and Turmeric oil on cognitive function in healthy adults: a 24 weeks, randomized double-blind, placebo-controlled trial
Scientific Title:Acronym Association of "Gingko biloba extract with Sesame extract and Turmeric oil" with cognitive function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to explore the influence of the mixture of Gingko biloba extract with improved bioavailability agents on the alteration of cognitive function in healthy adults.
Basic objectives2 Others
Basic objectives -Others The primary aim of this study is to discover the influence of the mixture of Gingko biloba extract, Sesame extract and Turmeric oil (GBE/MST) on the alteration of cognitive function assessed by neuropsychological examinations.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint of this study is to discover any alteration of cognitive function in healthy adults assessed by Wechsler Memory Scale revised (WMS-R) following 24 weeks administration of GBE/MST.
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Two capsules of GBE/MST supplement and two tablets of placebo, once a day for 24 weeks
Interventions/Control_2 Two tablets of GBE supplement and two capsules of placebo, once a day for 24 weeks
Interventions/Control_3 Two capsules of placebo and two tablets of placebo, once a day for 24 weeks
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
20 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults who is confirmed with a written informed consent. Normal cognitive function at baseline is confirmed by Montreal Cognitive Assessment battery Japanese version (more than 26).
Key exclusion criteria 1) With past history of severe neurological diseases.
2) With critical bleeding incidents.
3) Use of antithrombotic medicine.
4) Severe depression
5) Patients with diabetes mellitus.
6) With severe visual or auditory disability.
7) Individuals with any metal implantation, such as cardiac pacemaker, coronary stent and artificial joint.
8) Claustrophobia.
9) Use of any supplement.
10) Creatinine clearance less than 15ml/min.
11) Patients with gastrointestinal diseases or metabolic diseases.
12) Diagnosed psychiatric disorders.
13) Participants who cannot obtain the informed consent.
14) Allergy to the study materials.
15) Individuals who is not suitable for participating in this study decided by principal investigator.
Target sample size 159

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Taki
Organization IDAC, Tohoku University
Division name Department of Nuclear Medicine and Radiology
Zip code 980-8575
Address 4-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
TEL 022-717-8559
Email yasuyuki.taki.c7@tohoku.ac.jp

Public contact
Name of contact person
1st name Taizen
Middle name
Last name Nakase
Organization IDAC, Tohoku University
Division name Department of Nuclear Medicine and Radiology
Zip code 980-8575
Address 4-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
TEL 022-717-8559
Homepage URL
Email taizen.nakase.a4@tohoku.ac.jp

Sponsor
Institute Department of Nuclear Medicine and Radiology
IDAC, Tohoku University
Institute
Department

Funding Source
Organization Ooki Pharmaceutical Company
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 Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
Tel 022-728-4105
Email med-kenkyo@grp.tohoku.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 東北大学加齢医学研究所

Other administrative information
Date of disclosure of the study information
2021 Year 05 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
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
2021 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2022 Year 07 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
2021 Year 03 Month 02 Day
Last modified on
2021 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049662

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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