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| Name | Class |
|---|---|
| Elegant And Olive Health Clinic, Canada | OTHER |
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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.
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 in 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 (PQi), 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 pharmacopedia "Compendium of Materia Medica" published in year 1,600. Nonetheless, although PQi 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, WM 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 (a type of white blood cells that are important for protection against infections), and other immunocytes (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. A previous Pilot trial has been conducted that aimed 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, would improve Protective Qi in subjects diagnosed by practitioners of TCM as having low or insufficient Protective Qi. The data obtained demonstrated a statistically significant effect of Proglucamune on improving PQi. Based on the effect size and variability, investigators have arrived, via statistical methods, at the necessary sample size for a more definitive (placebo-controlled, randomized, and triple-blinded) trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proglucamune treatment | Experimental | Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 8 weeks. |
|
| Placebo | Placebo Comparator | Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta glucan | Dietary Supplement | Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) 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 | Description | Time Frame |
|---|---|---|
| Change in Severity Score of Protective Qi Deficiency | The severity score of Protective Qi Deficiency in all participants will be assessed at baseline and each follow-up visit by on-site investigators (licensed TCM practitioners). Each health condition relevant to Protective Qi Deficiency(PQD) (i.e., cold frequency, symptoms, and signs) will be scored on a designed scale (with higher number indicating more severe condition/symptom) based on a set of standardized and specified criteria (see uploaded Study Protocol for specifics). The sub-scores are then weighted (cold frequency 25%, symptoms 33.3%, signs: 41.7%) to arrive at a final PQD severity score. This score is on a 1-5 scale, with 5 being the most severe deficiency. The change of the score from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means. | The participants PQD severity score will be re-evaluted every two weeks for a total of 12 weeks. |
| Change of PQD Status as Asessed by Traditional Methods. | PQD status of each participant at baseline and each follow-up visit will be measured by on-site investigators (licensed TCM practitioners) through qualitative traditional assessment based on TCM practitioners' clinical experience. The status was characterized as non-PQD or PQD. The change of PQD status from baseline, indicating a treatment effect, will be calculated and analyzed by categorical statistics. | The participants will be followed every two weeks for a total of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Health_Physical Health | The participants' Global Health will be assessed using the established PROMIS® Scale v1.2 . This questionnaire consists of 10 global-health related questions. The answer for nine of ten questions are graded on 1-5 scale (with 5 being the best), and one question is graded on 1 to 10 scale (with 10 being the worst grade). The sub-scores are used to obtain a final combined score of Global Health using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent more. Higher scores indicate better physical health. |
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Inclusion Criteria:
Exclusion Criteria:
participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Ira Bernstein, MD | Department of Family and Community Medicine, Humber River Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elegant And Olive Health Clinic | Markham | Ontario | L3R 5V6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25146160 | Background | Keller SD, Yang M, Treadwell MJ, Werner EM, Hassell KL. Patient reports of health outcome for adults living with sickle cell disease: development and testing of the ASCQ-Me item banks. Health Qual Life Outcomes. 2014 Aug 22;12:125. doi: 10.1186/s12955-014-0125-0. | |
| 25832617 | Background | Hays RD, Spritzer KL, Thompson WW, Cella D. U.S. General Population Estimate for "Excellent" to "Poor" Self-Rated Health Item. J Gen Intern Med. 2015 Oct;30(10):1511-6. doi: 10.1007/s11606-015-3290-x. Epub 2015 Apr 2. |
| Label | URL |
|---|---|
| description for Global Health Questionnaire (PROMIS® Scale v1.2.) | View source |
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Of 207 enrolled participants, 138 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proglucamune Treatment | Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). |
| FG001 | Placebo | Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proglucamune Treatment | Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Severity Score of Protective Qi Deficiency | The severity score of Protective Qi Deficiency in all participants will be assessed at baseline and each follow-up visit by on-site investigators (licensed TCM practitioners). Each health condition relevant to Protective Qi Deficiency(PQD) (i.e., cold frequency, symptoms, and signs) will be scored on a designed scale (with higher number indicating more severe condition/symptom) based on a set of standardized and specified criteria (see uploaded Study Protocol for specifics). The sub-scores are then weighted (cold frequency 25%, symptoms 33.3%, signs: 41.7%) to arrive at a final PQD severity score. This score is on a 1-5 scale, with 5 being the most severe deficiency. The change of the score from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | The participants PQD severity score will be re-evaluted every two weeks for a total of 12 weeks. |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proglucamune Treatment | Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). |
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Since the treatment (Proglucamune) is a mixture of extract from yeast and whole mushrooms (Reishi and Shiitaki), we cannot completely rule out the possibility that some compounds other than ß-glucan present in Proglucamune may have contributed to the observed effect. This is particularly so given that Reishi, known for boosting Qi in TCM, contains a variety of other biologically active compounds .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy Tian | USANA Health Sciences | 01-801-954-7658 | jeremy.tian@usanainc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 18, 2022 | Jun 14, 2022 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Individuals with Protective Qi Insufficiency
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All participants, on-site care-providers and investigators, and the outcome assessors will be informed that this study is placebo controlled, and that each participant has a 50/50 chance of receiving treatment or placebo. The test material will include treatment and placebo, both coated by the same coating. The code will be kept by the sponsor and disclosed after the analyses are completed.
|
| The participants will be followed every two weeks for a total of 12 weeks. |
| Global Health_Mental Health | The participants' Global Health will be assessed using the established PROMIS® Scale v1.2. This questionnaire consists of 10 global-health related questions. The answer for nine of ten questions are graded on 1-5 scale (with 5 being the best), and one question is graded on 1 to 10 scale (with 10 being the worst grade). The sub-scores are used to obtain a final combined score of Global Health using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores present more. Higher scores indicate better mental health. | The participants will be followed every two weeks for a total of 12 weeks. |
| Saliva sIgA Secretion Rate | The effect of Proglucamune on the participants' immunity will be assessed by the change of saliva secretary IgA. | The participants will be followed every 6 weeks during 12 week trial. |
| Emotional and Behavioral Dyscontrol - Short Form | Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. This questionnaire consists of 8 questions related to emotional and behavioral control. The answers for each of the questions are graded on five levels from best to worst. A combined score is generated using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent more. Higher Emotional and Behavioral Dyscontrol scores represent worse Emotional and Behavioral Dyscontrol. | The participants will be followed every two weeks for a total of 12 weeks. |
| Emotional Impact | The participants' Emotional status will be assessed using the ASCO-Me® v2.0 Emotional Impact (Short Form). This questionnaire-based survey was established based on a Sickle-cell patient population (Please see the link http://www.ascq-me.org/Science or the citation below for detail). This questionnaire consists of 5 emotional-status related questions. The answer for each of the questions are graded on five levels from best to worst. A combined score is generated using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent better health. | The participants will be followed every two weeks for a total of 12 weeks. |
| Generic Qi Change | The generic Qi status of participants at baseline and each follow-up visit will be assessed by on-site investigators (licensed TCM practitioners). Each health condition relevant to generic Qi insufficiency (including history, symptoms, and signs) will be scored based on a standardized criteria, and then weighted to arrive at a final generic Qi Insufficiency Score. This score is on a 1-5 scale, with 5 being the most severe insufficiency. The change of the score from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means. | The participants will be followed every two weeks for a total of 12 weeks. |
| 33963479 | Derived | Wu JR, Cheng HJ, Shi JP, Yin WD, Wang J, Ou XQ, Chen JL, Bernstein I, Levy M, Maddela R, Sinnott R, Tian JQ. beta -Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency-A Randomized, Placebo-Controlled, and Double-Blinded Trial. Chin J Integr Med. 2022 May;28(5):394-402. doi: 10.1007/s11655-021-3444-0. Epub 2021 May 8. |
| description for Emotional \& Behavioral Dyscontrol Questionnaire (Neuro-QoL) | View source |
| BG001 | Placebo | Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Protective Qi Deficiency (PQD) | Protective Qi Deficiency of each participant is diagnosed by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Count of Participants | Participants |
|
| Severity Score of PQD | The severity score is based upon the weighted diagnosis of 7 symptoms by Traditional Chinese Medicine practitioners. The severity score ranges fronm 1- 5; 5 is considered the worst outcome and the individual exhibits severe PQD; conversely, 1 indicates that the individual exhibits no PQD. The weighted score of the 7 symptoms is: [cold frequency*0.375+ (aversion to wind&cold +spontaneous sweating)/2 +(Pulse*0.3+Cun Pulse*0.5+Tongue*0.25+Low voice*0.2)]/3. | Mean | Standard Deviation | units on a scale |
|
| Tongue | The range of the tongue score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Median | Inter-Quartile Range | units on a scale |
|
| Low voice & apathy | The range of the Low voice & apathy(II) score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Median | Inter-Quartile Range | units on a scale |
|
| Cold frequency | It is a standardized numerical interval scale. The range of it is 0 - 3, and 3 is the worst outcome Score 0: No cold in the past 2 months Score 1: Once in the past 2 months Score 2: Twice in the past 2 months Score 3: 3 times or more in the past 2 months | Count of Participants | Participants |
|
| Spontaneous sweating | The range of the Spontaneous Sweating score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Median | Inter-Quartile Range | units on a scale |
|
| Aversion to wind & cold | The range of the Aversion to wind & cold score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Median | Inter-Quartile Range | units on a scale |
|
| Overall Pulse | The range of the Overall Pulse score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Median | Inter-Quartile Range | units on a scale |
|
| Cun Pulse | The range of the Cun Pulse score is 1- 5 and 5 is considered the worst outcome. It is scored by Traditional Chinese Medicine practitioner based on the investigators' clinical experience. | Mean | Standard Deviation | units on a scale |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Flu Vaccine | Count of Participants | Participants |
|
| Saliva sIgA Secretion Rate | Saliva sIgA data were missing due to insufficient saliva or other procedural reasons. | Median | Inter-Quartile Range | microgram/min |
|
| Medication | Count of Participants | Participants |
|
| Supplement | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Alcohol | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Proglucamune Treatment | Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune) per day for a total duration of 12 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). |
| OG001 | Placebo | Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 12 weeks. |
|
|
|
| Primary | Change of PQD Status as Asessed by Traditional Methods. | PQD status of each participant at baseline and each follow-up visit will be measured by on-site investigators (licensed TCM practitioners) through qualitative traditional assessment based on TCM practitioners' clinical experience. The status was characterized as non-PQD or PQD. The change of PQD status from baseline, indicating a treatment effect, will be calculated and analyzed by categorical statistics. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| Secondary | Global Health_Physical Health | The participants' Global Health will be assessed using the established PROMIS® Scale v1.2 . This questionnaire consists of 10 global-health related questions. The answer for nine of ten questions are graded on 1-5 scale (with 5 being the best), and one question is graded on 1 to 10 scale (with 10 being the worst grade). The sub-scores are used to obtain a final combined score of Global Health using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent more. Higher scores indicate better physical health. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | T-score | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| Secondary | Global Health_Mental Health | The participants' Global Health will be assessed using the established PROMIS® Scale v1.2. This questionnaire consists of 10 global-health related questions. The answer for nine of ten questions are graded on 1-5 scale (with 5 being the best), and one question is graded on 1 to 10 scale (with 10 being the worst grade). The sub-scores are used to obtain a final combined score of Global Health using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores present more. Higher scores indicate better mental health. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | T-score | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| Secondary | Saliva sIgA Secretion Rate | The effect of Proglucamune on the participants' immunity will be assessed by the change of saliva secretary IgA. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Median | 95% Confidence Interval | microgram/min | The participants will be followed every 6 weeks during 12 week trial. |
|
|
|
|
| Secondary | Emotional and Behavioral Dyscontrol - Short Form | Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. This questionnaire consists of 8 questions related to emotional and behavioral control. The answers for each of the questions are graded on five levels from best to worst. A combined score is generated using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent more. Higher Emotional and Behavioral Dyscontrol scores represent worse Emotional and Behavioral Dyscontrol. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | T-score | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| Secondary | Emotional Impact | The participants' Emotional status will be assessed using the ASCO-Me® v2.0 Emotional Impact (Short Form). This questionnaire-based survey was established based on a Sickle-cell patient population (Please see the link http://www.ascq-me.org/Science or the citation below for detail). This questionnaire consists of 5 emotional-status related questions. The answer for each of the questions are graded on five levels from best to worst. A combined score is generated using a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent better health. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | T-score | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| Secondary | Generic Qi Change | The generic Qi status of participants at baseline and each follow-up visit will be assessed by on-site investigators (licensed TCM practitioners). Each health condition relevant to generic Qi insufficiency (including history, symptoms, and signs) will be scored based on a standardized criteria, and then weighted to arrive at a final generic Qi Insufficiency Score. This score is on a 1-5 scale, with 5 being the most severe insufficiency. The change of the score from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means. | Intent to Treat Population (all participants assigned to Proglucamune Treatment or Placebo). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | The participants will be followed every two weeks for a total of 12 weeks. |
|
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Placebo | Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 12 weeks. beta glucan: Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 12 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). | 0 | 68 | 0 | 68 | 0 | 68 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| PQD status in the Treatment group and Control group at 2 weeks (visit 2) |
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| PQD status in the Treatment group and Control group at 4 weeks (visit 3) |
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| PQD status in the Treatment group and Control group at 6 weeks (visit 4) |
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| PQD status in the Treatment group and Control group at 8 weeks (visit 5) |
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| PQD status in the Treatment group and Control group at 10 weeks (visit 6) |
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| PQD status in the Treatment group and Control group at 12 weeks (visit 7) |
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| Physical Health Score between treatment group and control group at 4 weeks (visit 3) |
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| Physical Health Score between treatment group and control group at 6 weeks (visit 4) |
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| Physical Health Score between treatment group and control group at 8 weeks (visit 5) |
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| Physical Health Score between treatment group and control group at 10 weeks (visit 6) |
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| Physical Health Score between treatment group and control group at 12 weeks (visit 7) |
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| Mental Health Score between treatment group and control group at 4 weeks (visit 3) |
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| Mental Health Score between treatment group and control group at 6 weeks (visit 4) |
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| Mental Health Score between treatment group and control group at 8 weeks (visit 5) |
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| Mental Health Score between treatment group and control group at 10 weeks (visit 6) |
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| Mental Health Score between treatment group and control group at 12 weeks (visit 7) |
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| Saliva sIgA Secretion Rate between treatment group and control group at 12 weeks (visit 7) |
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| Emotional&Behavioral Dyscontrol score between treatment and control groups at 4 weeks (visit 3) |
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| Emotional&Behavioral Dyscontrol score between treatment and control groups at 6 weeks (visit 4) |
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| Emotional&Behavioral Dyscontrol score between treatment and control groups at 8 weeks (visit 5) |
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| Emotional&Behavioral Dyscontrol score between treatment and control groups at 10 weeks (visit 6) |
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| Emotional&Behavioral Dyscontrol score between treatment and control groups at 12 weeks (visit 7) |
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| Emotional Impact score between treatment group and control group at 4 weeks (visit 3) |
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| Emotional Impact score between treatment group and control group at 6 weeks (visit 4) |
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| Emotional Impact score between treatment group and control group at 8 weeks (visit 5) |
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| Emotional Impact score between treatment group and control group at 10 weeks (visit 6) |
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| Emotional Impact score between treatment group and control group at 12 weeks (visit 7) |
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| Generic Qi between treatment group and control group at 4 weeks (visit 3) |
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| Generic Qi between treatment group and control group at 6 weeks (visit 4) |
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| Generic Qi between treatment group and control group at 8 weeks (visit 5) |
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| Generic Qi between treatment group and control group at 10 weeks (visit 6) |
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| Generic Qi between treatment group and control group at 12 weeks (visit 7) |
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