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

Chonbuk National University

Status: Completed

Conditions: Immunity

Treatments: Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g; Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02244372

CHE-PI-CM

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-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)

Enrollment: 90 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Cordyceps sinensis mycelium culture extract 0.76 g

Experimental group

Description:

Cordyceps sinensis mycelium culture extract 0.76 g

Treatment:

Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g

Cordyceps sinensis mycelium culture extract 1.15 g

Experimental group

Description:

Cordyceps sinensis mycelium culture extract 1.15 g

Treatment:

Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo