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Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People

Primary Purpose

Fatigue Syndrome, Chronic, Cold

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Antrodia cinnamomea mycelia
Placebo
Sponsored by
Greenyn Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fatigue Syndrome, Chronic

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects are easy to feel fatigued Subjects have poor sleep quality Exclusion Criteria: Pregnant women or preparing for pregnancy. Lactating women. Women gave birth 6 months before the study. Poor kindy and livers funcitons Severe cardiovascular or other chronic diseases Alcohol abuser Using immune-associated supplements

Sites / Locations

  • WanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Treatment

Arm Description

Placeo group

Experimental group

Outcomes

Primary Outcome Measures

Immune analysis
Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.
Immune analysis
Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
Cytokine analysis
Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.
Cytokine analysis
Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.
Cytokine analysis
Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.
Cytokine analysis
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
Cytokine analysis
Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
June 29, 2023
Sponsor
Greenyn Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05728918
Brief Title
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Official Title
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Greenyn Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.
Detailed Description
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic, Cold

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placeo group
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Experimental group
Intervention Type
Dietary Supplement
Intervention Name(s)
Antrodia cinnamomea mycelia
Intervention Description
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule, two capsules/day (600 mg/day) for 3 months
Primary Outcome Measure Information:
Title
Immune analysis
Description
Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Immune analysis
Description
Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Antibody analysis
Description
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Antibody analysis
Description
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Antibody analysis
Description
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Antibody analysis
Description
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Antibody analysis
Description
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Cytokine analysis
Description
Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Cytokine analysis
Description
Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Cytokine analysis
Description
Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Cytokine analysis
Description
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks
Title
Cytokine analysis
Description
Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.
Time Frame
Baseline up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are easy to feel fatigued Subjects have poor sleep quality Exclusion Criteria: Pregnant women or preparing for pregnancy. Lactating women. Women gave birth 6 months before the study. Poor kindy and livers funcitons Severe cardiovascular or other chronic diseases Alcohol abuser Using immune-associated supplements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Shun Wu, MD
Phone
+886-229307930
Email
mswu@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, MD
Organizational Affiliation
WanFang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
WanFang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, MD
Phone
+886-229307930
Email
mswu@tmu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People

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