Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

NCT ID: NCT02244372

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-02-28

Brief Summary

The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)

Conditions

Immunity

Study Design

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

Study Groups

Cordyceps sinensis mycelium culture extract 0.76 g

Cordyceps sinensis mycelium culture extract 0.76 g

Group Type: EXPERIMENTAL

Cordyceps sinensis mycelium culture extract 0.76 g

Intervention Type: DIETARY_SUPPLEMENT

Cordyceps sinensis mycelium culture extract 1.15 g

Cordyceps sinensis mycelium culture extract 1.15 g

Group Type: EXPERIMENTAL

Cordyceps sinensis mycelium culture extract 1.15 g

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Cordyceps sinensis mycelium culture extract 0.76 g

Intervention Type: DIETARY_SUPPLEMENT

Cordyceps sinensis mycelium culture extract 1.15 g

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Males and females 20-80 years old
• Who had suffered more than twice Upper respiratory infection* disorder or common cold causing URI
• Able to give informed consent

Exclusion Criteria

• WBC concentration below 3000 ㎕
• Subjects vaccinated against influenza within the last 6 months prior to the study
• Subjects with Upper respiratory infection at screening visit
• Subjects with BMI < 18.5 kg/m2 at screening visit
• Allergic or hypersensitive to any of the ingredients in the test products
• Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
• History of alcohol or substance abuse
• Participation in any other clinical trials within past 2 months
• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
• Pregnant or lactating women etc.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 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

CHE-PI-CM

Identifier Type: -

Identifier Source: org_study_id