Status:
UNKNOWN
Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) 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 ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity
Detailed Description
This study was 8 weeks, randomized, double-blind, placebo-controlled human trial. 120 subjects were randomly divided into ethanol extracts of Porphyra tenera(PTE10) group or placebo group. The investi...
Eligibility Criteria
Inclusion
- Males and females aged 50 years over at the screening
- Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Exclusion
- Patients whose white blood cell(WBC)\<3000/㎕ or \>8000/㎕ in the screening examination
- Patients receiving influenza vaccination within 3 months before the screening examination
- Patients who have a body mass index(BMI)\<18.5 kg / m\^2 or ≥35 kg / m\^2 at the screening examination
- Patients with 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
- Patients who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination
- Patients receiving antipsychotic medication within 3 months prior to the screening examination
- Patients who alcoholic or drug abuse suspected
- Patients who have participated in other clinical trials within 3 months prior to the screening examination
- Patients who show the following relevant results in a Laboratory test
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
- Serum Creatinine \> 2.0 mg/dl
- Patients who are pregnant or breastfeeding
- Patients who may become pregnant and have not used appropriate contraceptives
- Patients who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Key Trial Info
Start Date :
June 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04017988
Start Date
June 13 2019
End Date
April 30 2020
Last Update
July 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907