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

Fatigue Syndrome, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728918
• Other study ID #: A-111-091
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Greenyn Biotechnology Co., Ltd.
• Contact: Ming-Shun Wu, MD
• Phone: +886-229307930
• Email: mswu[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: April 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cold
• Fatigue Syndrome, Chronic

Intervention

Dietary Supplement:
• Antrodia cinnamomea mycelia
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months
• Placebo
Placebo capsule, two capsules/day (600 mg/day) for 3 months

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Greenyn Biotechnology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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