CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Proglucamunedietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03829228
NCT03829228N/ACompleted

An Evaluation of Proglucamune in the Treatment of Protective Qi

USANA Health Sciences·interventional·Posted Feb 4, 2019·Updated Oct 27, 2021

In Brief

A clinical study evaluating Proglucamune for Protective Qi Insufficiency. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartMar 18, 2018
Primary CompletionJun 3, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.4 years ago

Interventions

Proglucamunedietary

Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained \~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).