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

Immunity Clinical Trial

Official title:

A 8-week, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244372
• Other study ID #: CHE-PI-CM
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• Cordyceps sinensis mycelium culture extract 0.76 g

• Cordyceps sinensis mycelium culture extract 1.15 g

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cytotoxicity	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	4, 8 weeks
Secondary	Changes in Cytokine(IL-4, IL-6, IL-12, IFN-?, TNF-a)	Cytokine(IL-4, IL-6, IL-12, IFN-?, TNF-a) was measured in study visit 1(0 week), visit 2(4 week), and visit 3(8 week).	4, 8 weeks
Secondary	Changes in hs-CRP	hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).	4, 8 weeks