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

Chonbuk National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Immunity

Treatments

Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.68 g

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02814617

CBG-PI-CME

Details and patient eligibility

About

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-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).

Enrollment

80 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and females 20-75 years old
Able to give informed consent

Exclusion criteria

WBC concentration below 3000 ㎕, over 8000㎕
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.