Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
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ClinicalTrials.gov Identifier: NCT02244372 |
Recruitment Status :
Completed
First Posted : September 19, 2014
Last Update Posted : August 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Immunity | Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | February 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Cordyceps sinensis mycelium culture extract 0.76 g
Cordyceps sinensis mycelium culture extract 0.76 g
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Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g |
Experimental: Cordyceps sinensis mycelium culture extract 1.15 g
Cordyceps sinensis mycelium culture extract 1.15 g
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Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g |
Placebo Comparator: Placebo
Placebo
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Dietary Supplement: Placebo |
- 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
- 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).
- 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).

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244372
Korea, Republic of | |
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | |
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822 |
Responsible Party: | Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital |
ClinicalTrials.gov Identifier: | NCT02244372 |
Other Study ID Numbers: |
CHE-PI-CM |
First Posted: | September 19, 2014 Key Record Dates |
Last Update Posted: | August 22, 2019 |
Last Verified: | August 2019 |
Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2) immunity |