UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035765 |
|---|---|
| Receipt number | R000040722 |
| Scientific Title | The effects of Isaria japonica on cognitive function:An exploratory clinical study |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2021/11/15 16:02:33 |
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Basic information
Public title
The effects of Isaria japonica on cognitive function:An exploratory clinical study
Acronym
The effects of Isaria japonica on cognitive function
Scientific Title
The effects of Isaria japonica on cognitive function:An exploratory clinical study
Scientific Title:Acronym
The effects of Isaria japonica on cognitive function
Region
| Japan |
Condition
Condition
Cognitive impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Isaria japonica-containing food on cognitive function for people with mild cognitive decline
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of mini-mental state examination (MMSE) score
Key secondary outcomes
1)Changes in domain of MMSE score
2)Changes of oxidative stress, inflammatory, dementia related markers
3)Changes of behavioral and psychological symptoms of dementia (BPSD)
4)Changes of quality of life (QOL)
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
Period of intervention 12 weeks,
Health Supplement Cordyceps,
Intake twice a day after dinner in the morning and evening
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A person have mild cognitive decline: MMSE score 20-27 point
2) Prior to the research participation, the applicant and the person in charge of the document have obtained consent from the documents.
3) Age is 60 years old or older
4) A person who can cooperate in the intake and investigation of 12-week trial food
5) A person who can forbid the intake of supplements that affect the cognitive function one week before intake and during the intake period
Key exclusion criteria
1)A person who are allergic to cordyceps or silk or mushrooms
2) A person who has severe cardiac or and liver or renal function decline
3) A person who is taking dementia treatment drugs
4) A person who is given priority in drug treatment or surgical treatment as a cause of cognitive decline
5) A person who is judged unfit by the physician in charge of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
0542645102
dfuru@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
0542645102
Homepage URL
dfuru@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Biococoon Laboratories, Inc.
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
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel
0542645102
dfuru@u-shizuoka-ken.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 08 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040722
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
