An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency

• Sponsor: USANA Health Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03829228
• Collaborator: Elegant And Olive Health Clinic, Canada (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Protective Qi Insufficiency	Dietary Supplement: Proglucamune	N/A

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 tested in clinical studies that statistically demonstrate the efficacy at the populational level for applicable patients, and this makes it difficult to objectively evaluate and compare different therapies. The lack of clinical studies stands as a barrier for the advance of AMs as well as their engagement with WM. In fact, most researchers view AMs primarily as untapped sources of "active ingredients/compounds" for drug development, but disregard the rationales under which the therapies were developed. A "One-Way-Traffic" research paradigm is thus created wherein AM therapies are investigated for their efficacy by WM standards, whereas the vast potential of employing WM therapies for AM therapeutics is ignored. In light of this, investigators set up a novel strategy that bridges TCM and WM, i.e., testing a WM-based therapy by TCM standards through clinical trial/statistics- based method.

Qi is a central concept of traditional Chinese medicine (TCM) and was first documented in the oldest TCM writings more than 2000 years ago. Generally speaking, Qi refers to the vital energy of the body and is derived from two primary sources: 1) inborn Qi (that may be construed as genetics), and 2) pectoral Qi (can be construed as metabolism). Moreover, Qi manifests itself in two forms: Nutritive Qi and Protective Qi, which can be understood to reflect an individual's nutritional state and immune health, respectively. Regarding the latter, protective Qi functions to defend the body from the invasion of external pathogens. TCM also emphasizes that Protective Qi 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.

TCM has developed a number of methods to strengthen the Qi. Prominent among these is the use of Reishi, either alone or in combination with other TCM remedies. The use of Reishi was described in detail in the first TCM pharmacopeia "Compendium of Materia Medica" published in year 1,600. Nonetheless, although Protective Qi is part of the general Qi, the specific effect of Reishi on Protective Qi is less documented. Anecdotal reports are available that claim significant improvement of Protective Qi with Reishi or Reishi-containing formulas within days. Notably, Western medicine has identified immune-boosting properties of Reishi, which may explain the Qi enhancing effects of this plant. Specifically, beta-glucan - a component of Reishi - has been shown to activate macrophage (large white blood cells in the immune system that destroy bacteria and other harmful substances), neutrophil (type of white blood cells that are important for protection against infections), and other immunocytes (a type of cells capable of producing an immune response), and may exhibit particular benefits among macrophage-rich organs such as the lung, liver and spleen. In fact, ß-glucans from sources other than Reishi, such as baker's yeast, are able to initiate the same immune response and clinical benefits.

The overlap of TCM and western medicine concerning the beneficial effects of Reishi for its Qi enhancing and immune-modulating effects, respectively, has prompted us to investigate whether or not Reishi, in conjunction with other natural products used in TCM, can enhance an individual's Protective Qi. More specifically, the objective of the current protocol is to determine if a commercially available dietary supplement (Proglucamune®, USANA Health Sciences) containing powdered Reishi and Shitake mushrooms as well as baker's yeast extract, and which is comprised of 11% ß-glucans by weight, will improve Protective Qi in subjects diagnosed by practitioners of TCM as having low or insufficient Protective Qi. Specifically, in this a pilot study, 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. The trial also aimed to provide information on individuals who are responsive to Proglucamune treatment (responder), and subsequently recruit targeted individuals for the follow-up trials.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects with Protective Qi InsufficiencySubjects with Protective Qi Insufficiency
• Masking: None (Open Label)
• Masking Description: Given the small sample size in this pilot study and the potential drop-out rate, we did not include a placebo group to control for the placebo effect. Nonetheless, we implemented a "deceptive" double-blinding design, i.e., all on-site care-providers and investigators and all participants were told that this study was placebo controlled, and that each participant had a 50/50 chance of receiving treatment or placebo. This masking helps decreasing the expectation bias from the participants that confound the study result.
• Primary Purpose: Treatment
• Official Title: An Evaluation of Proglucamune in the Treatment of Protective Qi
• Actual Study Start Date: Mar 18, 2018
• Actual Primary Completion Date: Jun 3, 2018
• Actual Study Completion Date: Jun 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proglucamune treatment Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.	Dietary Supplement: Proglucamune; 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).

Outcome Measures

Primary Outcome Measures

1. Change of Protective Qi Score (PQS) Determined by a Standardized Assessment [The change of PQS was obtained by assessment of PQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.]

   Protective Qi of each participant at baseline and each follow-up visit will be measured by an on-site investigator (licensed TCM practitioners) through a standardized quantitative assessment. The evaluation includes 3 health conditions relevant to PQD (cold frequency, symptoms, and signs). Each condition will be scored on a 1-10 scale based on a set of standardized criteria. The sub-scores will be weighted to arrive at a final PQS. So this PQS will be on a 1-10 scale, with 10 being the most healthy state. The change of the PQS from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.

2. Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment [PQi status was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.]

   PQi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through the traditional TCM assessment, which was diagnosed based on investigators' experience. The evaluation includes 3 health conditions relevant to Protective Qi Deficiency (cold history, symptoms, and signs) but was neither standardized nor quantitative. PQi status was characterized as non-PQD (i.e., healthy condition, no PQD detected) or PQD (i.e., unhealthy condition). The change of the PQi status from baseline, indicating the treatment effect, was analyzed by categorical statistic.

Secondary Outcome Measures

1. Change of Generic Qi Score (GQS) Determined by a Standardized Assessment [The change of GQS was obtained by deduction of GQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.]

   Generic Qi of each participant at baseline and each follow-up visit will be measured by an on-site investigator (licensed TCM practitioners) through a standardized quantitative assessment. The evaluation includes 5 sets of criteria indicative of Generic Qi insufficiency (cold history, symptoms of PQD, symptoms of Lung Qi Deficiency, symptoms of Heart and Spleen Deficiency, and signs of GQD). Each set will be scored on a 1-10 scales, with 10 being the most healthy state. The sub-scores will be averaged to arrive at a final GQS. So this GQS will be on a 1-10 scale, with 10 being the most healthy state. The change of the GQS from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.

2. Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment [GQi was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.]

   GQi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through the traditional TCM assessment,which was diagnosed based on investigators' experience and expertise. The evaluation was made through cold history, symptoms and signs but was neither standardized nor quantitative. GQi was characterized as Generic Qi Deficiency (GQD; unhealthy state) or non-GQD (healthy state). The change of the GQi status from baseline, indicating the treatment effect, was analyzed by rank-based statistic.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elegant And Olive Health Clinic	Markham	Ontario	Canada	L3R 5V6

Sponsors and Collaborators

• USANA Health Sciences
• Elegant And Olive Health Clinic, Canada

Investigators

• Principal Investigator: Ira Bernstein, MD, Department of Family and Community Medicine, Humber River Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 20, 2021

More Information

Publications

• Bashir KMI, Choi JS. Clinical and Physiological Perspectives of β-Glucans: The Past, Present, and Future. Int J Mol Sci. 2017 Sep 5;18(9). pii: E1906. doi: 10.3390/ijms18091906. Review.
• Chan GC, Chan WK, Sze DM. The effects of beta-glucan on human immune and cancer cells. J Hematol Oncol. 2009 Jun 10;2:25. doi: 10.1186/1756-8722-2-25. Review.

• Responsible Party: USANA Health Sciences
• ClinicalTrials.gov Identifier: NCT03829228
• Other Study ID Numbers: 201875
• First Posted: Feb 4, 2019
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by USANA Health Sciences: Protective Qi; Immunity

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the great Toronto area in Canada through advertisement and referral from other TCM practitioners. The enrollment was conducted at the Elegant and Olive Health Clinic at Markham, Canada. Subjects that met the criteria for inclusion were enrolled. The first participants was enrolled on March 18th,2018 and the last participant was enrolled in April 8th, 2018.
Pre-assignment Detail	There was no wash-out or run-in period. All participants were assigned to received Proglucamune treatment. No participants were excluded before the start of treatment.

Arm/Group Title	All Participants Received Proglucamune Treatment.
Arm/Group Description	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).
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
Overall Participants	29
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	47
Sex: Female, Male (Count of Participants)
Female	20 69%
Male	9 31%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	29 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Canada	29 100%
Medication (Count of Participants)
Yes	5 17.2%
No	24 82.8%
Supplement (Count of Participants)
Yes	10 34.5%
No	19 65.5%
Smoking (Count of Participants)
Yes	0 0%
No	29 100%
Alcohol (Count of Participants)
Yes	0 0%
No	29 100%

Outcome Measures

1. Primary Outcome

Title	Change of Protective Qi Score (PQS) Determined by a Standardized Assessment
Description	Protective Qi of each participant at baseline and each follow-up visit will be measured by an on-site investigator (licensed TCM practitioners) through a standardized quantitative assessment. The evaluation includes 3 health conditions relevant to PQD (cold frequency, symptoms, and signs). Each condition will be scored on a 1-10 scale based on a set of standardized criteria. The sub-scores will be weighted to arrive at a final PQS. So this PQS will be on a 1-10 scale, with 10 being the most healthy state. The change of the PQS from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.
Time Frame	The change of PQS was obtained by assessment of PQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Outcome Measure Data

Analysis Population Description

Intent to treat population(all participants assigned to treatment). Last observation carried forward (LOCF) imputation method.

Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
Measure Participants	29
Baseline	6.3 (0.23)
Visit2	6.8 (0.17)
Visit3	7.17 (0.15)
Visit4	7.27 (0.18)
Visit5	7.64 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The threshold for statistical significance was p=0.01
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 0.62 to 2.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment Difference= Visit5-Baseline

2. Primary Outcome

Title	Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment
Description	PQi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through the traditional TCM assessment, which was diagnosed based on investigators' experience. The evaluation includes 3 health conditions relevant to Protective Qi Deficiency (cold history, symptoms, and signs) but was neither standardized nor quantitative. PQi status was characterized as non-PQD (i.e., healthy condition, no PQD detected) or PQD (i.e., unhealthy condition). The change of the PQi status from baseline, indicating the treatment effect, was analyzed by categorical statistic.
Time Frame	PQi status was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Outcome Measure Data

Analysis Population Description

Intent to treat population (all participants assigned to β-glucan treatment). Last observation carried forward (LOCF) imputation method.

Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
Measure Participants	29
Non-PQD	9 31%
PQD	20 69%
Non-PQD	10 34.5%
PQD	19 65.5%
Non-PQD	11 37.9%
PQD	18 62.1%
Non-PQD	19 65.5%
PQD	10 34.5%
Non-PQD	27 93.1%
PQD	2 6.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The threshold for statistical significance was p=0.01
	Method	Regression, Logistic
	Comments

3. Secondary Outcome

Title	Change of Generic Qi Score (GQS) Determined by a Standardized Assessment
Description	Generic Qi of each participant at baseline and each follow-up visit will be measured by an on-site investigator (licensed TCM practitioners) through a standardized quantitative assessment. The evaluation includes 5 sets of criteria indicative of Generic Qi insufficiency (cold history, symptoms of PQD, symptoms of Lung Qi Deficiency, symptoms of Heart and Spleen Deficiency, and signs of GQD). Each set will be scored on a 1-10 scales, with 10 being the most healthy state. The sub-scores will be averaged to arrive at a final GQS. So this GQS will be on a 1-10 scale, with 10 being the most healthy state. The change of the GQS from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.
Time Frame	The change of GQS was obtained by deduction of GQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Outcome Measure Data

Analysis Population Description

Intent to treat population (all participants assigned to β-glucan treatment. Last observation carried forward (LOCF) imputation method.

Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
Measure Participants	29
Baseline	6.34 (0.21)
Visit2	6.76 (0.16)
Visit3	7.16 (0.14)
Visit4	7.29 (0.17)
Visit 5	7.65 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The threshold for statistical significance was p=0.01
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment difference=Visit5-Baseline

4. Secondary Outcome

Title	Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment
Description	GQi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through the traditional TCM assessment,which was diagnosed based on investigators' experience and expertise. The evaluation was made through cold history, symptoms and signs but was neither standardized nor quantitative. GQi was characterized as Generic Qi Deficiency (GQD; unhealthy state) or non-GQD (healthy state). The change of the GQi status from baseline, indicating the treatment effect, was analyzed by rank-based statistic.
Time Frame	GQi was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Outcome Measure Data

Analysis Population Description

Intent to treat population (all participants assigned to β-glucan treatment). Last observation carried forward (LOCF) imputation method.

Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
Measure Participants	29
Non-GQD	4 13.8%
GQD	25 86.2%
Non-GQD	4 13.8%
GQD	25 86.2%
Non-GQD	8 27.6%
GQD	21 72.4%
Non-GQD	9 31%
GQD	20 69%
Non-GQD	19 65.5%
GQD	10 34.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The threshold for statistical significant was p=0.01.
	Method	Regression, Logistic
	Comments

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	Our treatment tablets are supplement. All participants don't have allege in rhinitis, pollinosis( hay fever), or asthma.
Arm/Group Title	All Participants
Arm/Group Description	Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Proglucamune: 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).
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/29 (0%)

Limitations/Caveats

Study limitations: First, this was not a randomized, placebo-controlled trial, so the observed effect size likely was inflated by uncontrolled confounders. Second, most participants were receptive to the healing effects of TCM, which may have lead to an overestimate of treatment effect. Lastly, the clinical trial started when flu season had passed its peak. This may have decreased the chance of subjects catching the flu and thereby have led to improved PQi independent of Proglucamune treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.