Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03829228
Eligibility Criteria:
Inclusion Criteria:
1. Male or females aged 18 to 65 years (inclusive) without regard to race or ethnic background
2. Provide a signed Informed Consent prior to entry in the study.
3. Willing to follow all study instructions and consume the assigned investigational product for 8 weeks.
4. Not currently taking a beta-glucan containing supplement or any other supplement that might interfere with the study design.
5. Ability to swallow tablets and pills.
6. Diagnosed as having Qi deficiency based on the following criteria:
* exhibit a history of susceptibility to cold\* (\* as defined in Traditional Chinese Medicine, TCM)
* exhibit a shortness of breath
* exhibit a lack of energy or excessive fatigue
* susceptible to spontaneous perspiration
* exhibit a corpulent tongue with or without white fur
* unwillingness to speak
* weak or powerless pulse
* pale complexion
Exclusion Criteria:
1. Persons diagnosed by TCM as having medical conditions other than low Qi.
2. Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study.
3. Persons with insulin-dependent and orally controlled diabetes will also be excluded from the study.
4. Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all of the necessary study visits.
5. Persons medically diagnosed with depression or anxiety disorders.
6. Persons with a history of alcohol abuse or other substance abuse within the previous 2 years.
7. Females who are attempting to become pregnant, pregnant, lactating or who have given birth within 1 year.
8. Persons who have had a medical surgery in the past 4 weeks.
9. Persons currently enrolled in a clinical trial, or who have completed a clinical trial within the last 4 weeks.
10. Allergies to mushrooms or other fungi.
11. Significant problems with constipation or diarrhea.
12. Persons exhibiting symptoms of cold\* (\*as defined by TCM) within the past 7 days.
13. A lifestyle or schedule incompatible with the study protocol.
14. Persons who are allergic to yeast products, have autoimmune disease/an immune disorder, or take antidepressants, blood thinners (anticoagulants), or immunosuppressant medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03829228
Study Brief:
Protocol Section:
NCT03829228