Status:
COMPLETED
Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Cognitive Function
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study was the efficacy and safety of Catechin high contain greentea extract on improvement of Cognitive Function
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo group. To evaluate t...
Eligibility Criteria
Inclusion
- Those who are at least 60 years of age at screening
- Those who have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points
- Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Exclusion
- Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Those with alcohol abuse or dependence within the last 3 months
- Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.)
- Those with a history of clinically significant hypersensitivity to green tea
- Those taking medicines, health functional foods or herbal medicines related to improvement of cognitive function and memory within 1 month before screening
- Those who ingested green tea extract's health functional food within 1 month before screening
- Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- Those who participate in other human tiral within 3 months
- Those who shows the following results in the Laboratory test
- AST, ALT \> 3 times upper limit of normal range
- Other significant laboratory test opinion
- Those who is deemed unsuitable for participating in the human trial due to other reasons
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03826017
Start Date
December 5 2018
End Date
October 8 2019
Last Update
July 16 2020
Active Locations (1)
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1
Department of Psychiatry, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907