N/A
Completed N=30
An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency
Protective Qi Insufficiency
Source: ClinicalTrials.gov NCT03829228 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change of Protective Qi Score (PQS) Determined by a Standardized Assessment — 6.3; 6.8; 7.17; 7.27 units on a scale — p=<0.0001
Summary
According to Traditional Chinese Medicine (TCM) principle, Protective Qi (PQi) is a one specific concept of Qi that provides the vital energy of the body. It works primarily on the body surface as a defensive barrier. In this context, PQi is analogous to anatomical barriers of the innate immune system located for example, at the skin surface and the mucosal surfaces of the respiratory and digestive tract. Individuals with PQi Insufficiency are predisposed to frequent cold and other symptoms caused by invasion of external pathogens ("Wai Xie" or "external evil" in TCM).
ß-glucan is a polysaccharide that activates macrophage (Dectin-1) and neutrophil (CR3) receptors, and therefore enhances immune defense at digestive and respiratory mucosa. Clinical trials have shown its immune activity such as preventing upper respiratory tract infection (URTI) and Traveler's diarrhea. Notably, ß-glucan is a component of Ganoderma Luciderm (or Reishi / Lingzhi), one TCM ingredient well-known for improving Qi. Based on this connection, investigators hypothesized that ß-glucan is the active ingredient in Reishi that at least partially accounts for Reishi's activity on Qi.
To test our hypothesis, investigators have conducted an uncontrolled pilot trial that investigated the effect of a commercially available, high ß-glucan containing product, Proglucamune®, on PQi status. Proglucamune contains ß-glucan from three different natural sources: Reishi mushroom, Shiitaki mushroom, and Bakers' yeast, each providing ß-glucan that differs slightly in their molecular structure. Through this pilot investigators sought to obtain an estimate of the effect size of Proglucamune on PQi that would allow us, via statistical methods, to estimate the necessary sample size for more definitive future trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Protective Qi Score (PQS) Determined by a Standardized Assessment |
6.3; 6.8; 7.17; 7.27; 7.64 | <0.0001 sig |
| PRIMARY Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment |
9; 20; 10; 19; 11; 18 | <0.0001 sig |
| SECONDARY Change of Generic Qi Score (GQS) Determined by a Standardized Assessment |
6.34; 6.76; 7.16; 7.29; 7.65 | <0.0001 sig |
| SECONDARY Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment |
4; 25; 4; 25; 8; 21 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 8 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.
- 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
- 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.
- Persons with insulin-dependent and orally controlled diabetes will also be excluded from 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.
- 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.
- Persons exhibiting symptoms of cold* (*as defined by TCM) within the past 7 days.
- 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), or immunosuppressant medication
Data sourced from ClinicalTrials.gov (NCT03829228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.