Status:
COMPLETED
A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Deficiency, a TCM Condition
Lead Sponsor:
USANA Health Sciences
Collaborating Sponsors:
Elegant And Olive Health Clinic, Canada
Conditions:
Protective Qi Insufficiency (a Condition Term From TCM)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a follow-up Phase II study of a previously complete pilot trial (Protocol ID: 201875) with the same goal: evaluating the activity of Proglucamune on Protective Qi (PQi) Insufficiency. Accordi...
Detailed Description
Unlike mainstream Western medicine (WM), alternative medicines (AM) such as Traditional Chinese Medicine (TCM), emphasizes individually-differentiated therapies. As such, AM therapies are normally not...
Eligibility Criteria
Inclusion
- Male or females aged 18 to 65 years (inclusive) without regard to race or ethnic background
- Provide a signed Informed Consent prior to entry in the study.
- Willing to follow all study instructions and consume the assigned investigational product for 12 weeks.
- Not currently taking a beta-glucan containing supplement or any other supplement that might interfere with the study design.
- Ability to swallow tablets and pills.
- Exhibit an PQi Insufficiency score \> 2 (See Primary Outcome Measure)
Exclusion
- Persons diagnosed by TCM as having medical conditions other than low Qi.
- 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.
- Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all of the necessary study visits.
- Persons medically diagnosed with depression or anxiety disorders.
- Persons with a history of alcohol abuse or other substance abuse within the previous 2 years.
- Females who are attempting to become pregnant, pregnant, lactating or who have given birth within 1 year.
- Persons who have had a medical surgery in the past 4 weeks or have scheduled a surgery during the study period.
- Persons currently enrolled in a clinical trial, or who have completed a clinical trial within the last 4 weeks.
- Allergies to mushrooms or other fungi.
- Significant problems with constipation or diarrhea.
- A lifestyle or schedule incompatible with the study protocol.
- Persons who are allergic to yeast products, have autoimmune disease/an immune disorder, or take antidepressants, blood thinners (anticoagulants, acetylsalicylic acid), or immunosuppressant medication
Key Trial Info
Start Date :
January 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2019
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT03782974
Start Date
January 6 2019
End Date
June 6 2019
Last Update
January 30 2024
Active Locations (1)
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1
Elegant And Olive Health Clinic
Markham, Ontario, Canada, L3R 5V6