Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
|ClinicalTrials.gov Identifier: NCT04010331|
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunity||Dietary Supplement: Nokyong Mixture Extract(CME-PI) Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||March 6, 2019|
|Actual Primary Completion Date :||May 6, 2019|
|Actual Study Completion Date :||May 30, 2019|
Experimental: Nokyong Mixture Extract(CME-PI) group
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.4g/day, Nokyong Mixture Extract(CME-PI) 1 g/day)
Dietary Supplement: Nokyong Mixture Extract(CME-PI)
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
Placebo Comparator: Placebo group
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.4g/day, Nokyong Mixture Extract(CME-PI) 0 g/day)
Dietary Supplement: Placebo
Placebo for 8 week
- Changes of Natural Killer cell activity [ Time Frame: 8 weeks ]
Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 50:1, 25:1, 12.5:1.
(Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
- Changes of Cytokines [ Time Frame: 8 weeks ]
For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes.
Inspection item were IL-2, IL-6, IL-12, IFN-γ, TNF-α.
- Changes of Upper respiratory infection questionnaire score [ Time Frame: 8 weeks ]
The upper respiratory infection questionnaire will investigate the occurrence of symptoms of upper respiratory infections (or symptoms), the score by symptom, the duration (days), and survey on the day of visit (1st, 2nd and 3rd visits).
The questionnaire items were classified into three groups according to whether or not the symptoms of upper respiratory infections (or symptoms) occurrence (yes or no), the types of symptoms (sore throat, rhinorrhea, nasal obstruction, sneezing, hoarseness, myalgia, earache, fever, headache, cough, sputum, dyspnea, diarrhea, nausea, vomiting)and symptoms level (0 if no symptoms, 1 if slightly, 2 if normal, 3 severe).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010331
|Korea, Republic of|
|Clinical Trial Center for Functional Foods Chonbuk National University Hospital|
|Jeonju, Jeollabuk-do, Korea, Republic of, 54907|