Fatigue Syndrome, ChronicNCT05728918
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
A study testing Antrodia cinnamomea mycelia in people with Fatigue Syndrome, Chronic and Cold, run by Greenyn Biotechnology Co., Ltd. at 1 site in Taiwan.
Trial summary
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic, Cold
- What is being tested?
- Antrodia cinnamomea mycelia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are easy to feel fatigued
- Subjects have poor sleep quality
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.
Read the 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.
- Conditions
- Fatigue Syndrome, Chronic, Cold
- Being tested
- Antrodia cinnamomea mycelia, Placebo
- Medical subject headings
- Fatigue Syndrome, Chronic, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antrodia cinnamomea myceliaDietary supplement
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months
PlaceboDietary supplement
Placebo capsule, two capsules/day (600 mg/day) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placeo group Receives: Dietary Supplement: Placebo |
| Treatment | Experimental | Experimental group Receives: Dietary Supplement: Antrodia cinnamomea mycelia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune analysis
Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Immune analysis
Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Antibody analysis
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Antibody analysis
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Antibody analysis
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Antibody analysis
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Antibody analysis
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Cytokine analysis
Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Cytokine analysis
Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Cytokine analysis
Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Cytokine analysis
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Cytokine analysis
Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Mar 2023
- Primary completion29 Feb 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Shun Wu, MD, Principal investigator, WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728918
- Sponsor's protocol ID
- A-111-091
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
- ClinicalTrials.gov ID
- NCT05728918
- Acronym / sponsor ID
- A-111-091
- Conditions
- Fatigue Syndrome, Chronic, Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlaceo group |
| Treatment | Experimental | Dietary Supplement: Antrodia cinnamomea myceliaExperimental group |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects are easy to feel fatigued
- Subjects have poor sleep quality
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antrodia cinnamomea myceliaAntrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months | Dietary supplement | Treatment |
| PlaceboPlacebo capsule, two capsules/day (600 mg/day) for 3 months | Dietary supplement | Placebo |
Primary outcome
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.
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.
Antibody analysis
Time frame: Baseline up to 4 weeks
Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Time frame: Baseline up to 4 weeks
Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Time frame: Baseline up to 4 weeks
Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Time frame: Baseline up to 4 weeks
Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.
Antibody analysis
Time frame: Baseline up to 4 weeks
Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.
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.
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.
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.
Cytokine analysis
Time frame: Baseline up to 4 weeks
Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shun Wu, MD principal investigator
WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antrodia cinnamomea mycelia in people with Fatigue Syndrome, Chronic and Cold, run by Greenyn Biotechnology Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune analysis (time frame: Baseline up to 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.