N/A
Completed N=138
A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Deficiency, a TCM Condition
Protective Qi Insufficiency (a Condition Term From TCM)
Source: ClinicalTrials.gov NCT03782974 ↗
Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Change in Severity Score of Protective Qi Deficiency — 2.66; 2.58; 2.50; 2.57 units on a scale — p=<0.0001
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.
According to Traditional Chinese Medicine (TCM) principle, Protective Qi 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, Protective Qi 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 Lucidum (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. The data obtained demonstrated a statistically significant effect of Proglucamune on improving PQi in individuals with PQi Insufficiency. The current study is aimed to further determine this effect in a more stringent (placebo-controlled, randomized, and triple-blinded) way.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity Score of Protective Qi Deficiency |
2.66; 2.58; 2.50; 2.57; 2.16; 2.56 | <0.0001 sig |
| PRIMARY Change of PQD Status as Asessed by Traditional Methods. |
60; 55; 10; 13; 54; 54 | <0.0001 sig |
| SECONDARY Global Health_Physical Health |
44.25; 44.85; 46.33; 45.34; 47.63; 45.71 | <0.001 sig |
| SECONDARY Global Health_Mental Health |
45.40; 46.52; 46.60; 46.83; 48.29; 47.26 | <0.05 sig |
| SECONDARY Saliva sIgA Secretion Rate |
93; 125; 68; 63; 86; 92 | 0.6 |
| SECONDARY Emotional and Behavioral Dyscontrol - Short Form |
45.80; 46.79; 45.22; 45.70; 45.08; 45.46 | 0.054 |
| SECONDARY Emotional Impact |
53.54; 53.43; 54.35; 54.00; 54.64; 53.93 | 0.13 |
| SECONDARY Generic Qi Change |
3.09; 2.97; 2.82; 2.90; 2.48; 2.87 | <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 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 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.
- 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
Data sourced from ClinicalTrials.gov (NCT03782974). 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.