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Completed

NCT Number: NCT02244372

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

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)

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Key information

Conditions

Immunity

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cordyceps sinensis mycelium culture extract 0.76 g

Dietary Supplement

Cordyceps sinensis mycelium culture extract 1.15 g

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Changes in Cytotoxicity

    Time frame: 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 outcomes

  1. Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)

    Time frame: 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).

  2. Changes in hs-CRP

    Time frame: 4, 8 weeks

    hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 19, 2014
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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