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出境医 / 临床实验 / Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Study Description
Brief Summary:
This study was conducted to investigate the efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immunity | Dietary Supplement: Nokyong Mixture Extract(CME-PI) Dietary Supplement: Placebo | Not Applicable |
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 measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| 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 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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).
Eligibility Criteria
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Locations
| Korea, Republic of | |
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | |
| Jeonju, Jeollabuk-do, Korea, Republic of, 54907 | |
Sponsors and Collaborators
Chonbuk National University Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 3, 2019 | ||||
| First Posted Date ICMJE | July 8, 2019 | ||||
| Last Update Posted Date | May 8, 2020 | ||||
| Actual Study Start Date ICMJE | March 6, 2019 | ||||
| Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity | ||||
| Official Title ICMJE | 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 | ||||
| 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 measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Immunity | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
80 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 30, 2019 | ||||
| Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04010331 | ||||
| Other Study ID Numbers ICMJE | DC-PI-CME | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Soo-Wan Chae, Chonbuk National University Hospital | ||||
| Study Sponsor ICMJE | Chonbuk National University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chonbuk National University Hospital | ||||
| Verification Date | May 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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