Imunoglukan PH4 syrup (10 mg of pleuran and 10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day.

A vitamin C syrup (10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight.

Diarrhoea;Acute

Children allocated to experimental group will receive Imunoglukan PH4 syrup (10 mg of pleuran and 10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.

Imunoglukan PH4

Children allocated to control group will receive a placebo: a vitamin C syrup (10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.

Placebo (vitamin C syrup)

The Department of Pediatrics with Clinical Assessment Unit, The Medical University of Warsaw

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children- a Randomized, Placebo-controlled, Double-blind Trial

The duration of diarrhoea, defined as the time (hours) until normalization of stool consistency (grade 2, 3, 4 or 5 according to Bristol Stool Form Scale) and until normalization of number of stools per day.

The length of hospital stay due to AGE (number of days).

The need for intravenous rehydration will be assessed daily by physician, based on CDC (Centers for Disease Control and Prevention) and WHO dehydration scales.

Assessed on the basis of the diary completed by the physician and the caregiver.

Assessed by the Modified Vesikari Scale in the end of observation.

The Study protocol will be publicly available during the Study commencement. Other documents (Statistical Analysis Plan, Clinical Research Form, Informed Consent Form) will be available on request from authorized institutions.
Individual deidentified participant data will be available upon reasonable request for researchers who provide a methodologically sound proposal that has been approved by an independent bioethical committee. This will be available immediately after study result publication, for a minimum of 5 years. To gain access, data requestors will need to sign a data access agreement.
Additionally, The Medical University of Warsaw committed to share with PLEURAN s.r.o. an unprocessed, deidentified participant data obtained during the Study.

Medical University of Warsaw

Nutricia Foundation

PLEURAN s.r.o.

This will be a randomized, double-blind, placebo-controlled trial, with allocation 1:1.

All patients, their caregivers, researchers, physicians, nurses, the statistician will be blinded to the intervention.

Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.

Protective Qi Insufficiency

participant eligibility is based on self-representation of gender identity.

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).

Proglucamune

Elegant And Olive Health Clinic

An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency

An Evaluation of Proglucamune in the Treatment of Protective Qi

Protective Qi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through a standardized quantitive assessment. The evaluation includes 3 health conditions relevant to protective Qi insufficiency (cold history, symptoms, and signs). Each condition was scored based on a set of standardized criteria on a 1-10 scale, with 10 being the most healthy state. The sub-scores were then averaged to arrive at a final PQS. This PQS was on a 1-10 scale, with 10 being the most healthy state. The change of the PQS from baseline, indicating the treatment effect, was calculated and analyzed by statistical means.

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. The evaluation includes 3 health conditions relevant to protective Qi insufficiency (cold history, symptoms, and signs) but was not standardized and quantitative. PQi was characterized by 4 levels, Normal PQi, Mild Insufficiency, Moderate Insufficiency, and Severe Insufficiency. The change of the PQi level from baseline, indicating the treatment effect, was analyzed by statistical means.

Generic Qi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through a standardized quantitive assessment. The evaluation included 2 sets of criteria indicative of Generic Qi insufficiency (symptoms, and signs). Each set was scored on a 1-10 scale, with 10 being the most healthy state. The sub-scores were then averaged to arrive at a final PQS. This GQS was on a 1-10 scale, with 10 being the most healthy state. The change of the GQS from baseline, indicating the treatment effect, was calculated and analyzed by statistical means.

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. The evaluation was made through symptoms and signs but was not standardized and quantitative. GQi was characterized by 4 levels in this method, Normal PQi, Mild Insufficiency, Moderate Insufficiency, and Severe Insufficiency. The change of the GQi level from baseline, indicating the treatment effect, was analyzed by statistical means.

USANA Health Sciences

Elegant And Olive Health Clinic, Canada

Subjects with Protective Qi Insufficiency

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.

Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 8 weeks.

Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 8 weeks.

Protective Qi Insufficiency (a Condition Term From TCM)

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).

beta glucan

description for Global Health Questionnaire (PROMIS® Scale v1.2.)

description for Emotional Impact Questionnaire: ASCO-Me® v2.0 Emotional Impact (Short Form)

description for Emotional & Behavioral Dyscontrol Questionnaire (Neuro-QoL)

A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Insufficiency, a TCM Condition

A Randomized, Placebo-controlled, Triple-blinded Evaluation of Proglucamune® in the Treatment of Protective Qi

The Protective 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 protective Qi insufficiency (i.e., cold history, symptoms, and signs) will be scored on a 1-10 or 1-5 scale (with higher number indicating more severe insufficiency) based on a set of standardized and specified criteria (see uploaded Study Protocol for specifics). The sub-scores are then weighted (cold history 25%, symptoms 33.3%, signs: 41.7%) to arrive at a final Protective Qi Insufficiency Index. This index 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 generic Qi status of participants at baseline and each follow-up visit will be assessed by on-site investigators (licensed TCM practitioners). The assessment consists of two parts of health conditions relevant to generic Qi insufficiency (symptoms and signs). Each part will be scored on a 1-5 scale (with 5 being the most severe insufficiency) based on a set of standardized and specified criteria (See uploaded Study Protocol). The sub-scores are then weighted (symptoms 40% and signs 60%) to arrive at a combined generic Qi Insufficiency Index. This index 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' Global Health will be assessed using the established PROMIS® Scale v1.2 (See the link http://www.healthmeasures.net/explore-measurement-systems/promis or the Citation below for detail). 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.

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.

The effect of Proglucamune on the participants' immunity will be assessed by the change of saliva secretary IgA.

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. Please see the link (http://www.healthmeasures.net/explore-measurement-systems/neuro-qol) for details. 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.

Individuals with Protective Qi Insufficiency

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.

glucan/diare

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency

A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Insufficiency, a TCM Condition

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