Status:
COMPLETED
Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Immunity
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study was conducted to investigate the efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Detailed Description
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Nokyong Mixture Extract(CME-PI) group or placebo group. The investigators mea...
Eligibility Criteria
Inclusion
- Adult men and women over 50 years
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Exclusion
- If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
- Those who received influenza vaccination within 3 months before the screening
- Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
- Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
- Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
- Those who have received antipsychotic medication within 3 months before screening
- Those who alcoholic or drug abuse suspected
- Those who participated in other clinical trials within 3 months before screening
- Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
- Serum Creatinine \> 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04010331
Start Date
March 6 2019
End Date
May 30 2019
Last Update
May 8 2020
Active Locations (1)
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1
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907