A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Nokyong Mixture Extract(CME-PI)
+ Placebo
Prevention Study
Summary
Study start date: March 6, 2019
Actual date on which the first participant was enrolled.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 measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, South KoreaOpen Clinical Trial Center for Functional Foods Chonbuk National University Hospital in Google Maps