Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
1 other identifier
interventional
25
1 country
1
Brief Summary
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedAugust 9, 2024
August 1, 2024
1 year
February 1, 2023
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (12)
Immune analysis
Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Immune analysis
Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Antibody analysis
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Cytokine analysis
Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.
Baseline up to 4 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlaceo group
Treatment
EXPERIMENTALExperimental group
Interventions
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months
Eligibility Criteria
You may qualify if:
- Subjects are easy to feel fatigued
- Subjects have poor sleep quality
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WanFang Hospital
Taipei, 116, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Shun Wu, MD
WanFang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 15, 2023
Study Start
March 1, 2023
Primary Completion
February 29, 2024
Study Completion
May 30, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08