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

February 21, 2024 updated by: Greenyn Biotechnology Co., Ltd.
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ming-Shun Wu, MD
  • Phone Number: +886-229307930
  • Email: mswu@tmu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Recruiting
        • WanFang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placeo group
Dietary supplement: Placebo
Placebo capsule, two capsules/day (600 mg/day) for 3 months
Experimental: Treatment
Experimental group
Dietary supplement: Antrodia cinnamomea mycelia
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune analysis
Time Frame: Baseline up to 4 weeks
Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Immune analysis
Time Frame: Baseline up to 4 weeks
Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Time Frame: Baseline up to 4 weeks
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Time Frame: Baseline up to 4 weeks
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Time Frame: Baseline up to 4 weeks
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Time Frame: Baseline up to 4 weeks
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Time Frame: Baseline up to 4 weeks
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Time Frame: Baseline up to 4 weeks
Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Time Frame: Baseline up to 4 weeks
Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Time Frame: Baseline up to 4 weeks
Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Time Frame: Baseline up to 4 weeks
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Time Frame: Baseline up to 4 weeks
Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greenyn Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Ming-Shun Wu, MD, WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-111-091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue Syndrome, Chronic

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe