Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity

NCT ID: NCT04010331

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2019-05-30

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.

Conditions

Immunity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Nokyong Mixture Extract(CME-PI)

Intervention Type: DIETARY_SUPPLEMENT

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo for 8 week

Interventions

Nokyong Mixture Extract(CME-PI)

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo for 8 week

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Principal investigator, Clinical Trial Center for Functional Foods

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

DC-PI-CME

Identifier Type: -

Identifier Source: org_study_id