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

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g; Dietary Supplement: Placebo; Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g

• Registration Number: NCT02244372
• Lead Sponsor: Chonbuk National University Hospital

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Study Completion: 2015-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cordyceps sinensis mycelium culture extract 1.15 g	Cordyceps sinensis mycelium culture extract 1.15 g	Cordyceps sinensis mycelium culture extract 1.15 g
Placebo	Placebo	Placebo
Cordyceps sinensis mycelium culture extract 0.76 g	Cordyceps sinensis mycelium culture extract 0.76 g	Cordyceps sinensis mycelium culture extract 0.76 g

Primary Outcome Measures

Name	Time	Method
Changes in Cytotoxicity	4, 8 weeks	Cytotoxicity was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). cytotoxicity was measured by NK cell activity.; Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100

Secondary Outcome Measures

Name	Time	Method
Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)	4, 8 weeks	Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) was measured in study visit 1(0 week), visit 2(4 week), and visit 3(8 week).
Changes in hs-CRP	4, 8 weeks	hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of