Status:
COMPLETED
Efficacy and Safety of Sesame Oil Cake 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 Sesame oil cake extract on improvement of Cognitive Function
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To evaluate the changes of t...
Eligibility Criteria
Inclusion
- Those who are at least 60 years of age at screening
- Those who word list memory / recollection/ recognition test scores of CERAD -K decrease 1-2 SD number of normal value
- 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 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 take any prescription medicines or herbal medicines within 2 weeks before the first ingestion date or take any OTC or vitamin preparations within 1 week
- Those who participate in other human trial within 2 months before the first ingestion
- Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- Those who is deemed unsuitable for participating in the human trial due to other reasons
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03826121
Start Date
September 15 2017
End Date
August 10 2018
Last Update
July 25 2019
Active Locations (1)
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1
Department of Psychiatry, Chonbuk National University Hospital
Jeonju, South Korea