Trial Outcomes & Findings for An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency (NCT NCT03829228)

Last Updated: 2021-10-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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.

Results posted on

2021-10-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Participants Received Proglucamune Treatment. 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 Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Received Proglucamune Treatment. 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 Study Protocol Violation	1

Baseline Characteristics

An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=29 Participants 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).
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	29 participants n=5 Participants
Medication Yes	5 Participants n=5 Participants
Medication No	24 Participants n=5 Participants
Supplement Yes	10 Participants n=5 Participants
Supplement No	19 Participants n=5 Participants
Smoking Yes	0 Participants n=5 Participants
Smoking No	29 Participants n=5 Participants
Alcohol Yes	0 Participants n=5 Participants
Alcohol No	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	All Participants n=29 Participants 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).
Change of Protective Qi Score (PQS) Determined by a Standardized Assessment Baseline	6.3 units on a scale Standard Error 0.23
Change of Protective Qi Score (PQS) Determined by a Standardized Assessment Visit2	6.8 units on a scale Standard Error 0.17
Change of Protective Qi Score (PQS) Determined by a Standardized Assessment Visit3	7.17 units on a scale Standard Error 0.15
Change of Protective Qi Score (PQS) Determined by a Standardized Assessment Visit4	7.27 units on a scale Standard Error 0.18
Change of Protective Qi Score (PQS) Determined by a Standardized Assessment Visit5	7.64 units on a scale Standard Error 0.16

PRIMARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	All Participants n=29 Participants 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).
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Baseline · Non-PQD	9 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Baseline · PQD	20 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit2 · Non-PQD	10 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit2 · PQD	19 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit3 · Non-PQD	11 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit3 · PQD	18 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit4 · Non-PQD	19 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit4 · PQD	10 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit5 · Non-PQD	27 Participants
Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment Visit5 · PQD	2 Participants

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	All Participants n=29 Participants 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).
Change of Generic Qi Score (GQS) Determined by a Standardized Assessment Baseline	6.34 units on a scale Standard Error 0.21
Change of Generic Qi Score (GQS) Determined by a Standardized Assessment Visit2	6.76 units on a scale Standard Error 0.16
Change of Generic Qi Score (GQS) Determined by a Standardized Assessment Visit3	7.16 units on a scale Standard Error 0.14
Change of Generic Qi Score (GQS) Determined by a Standardized Assessment Visit4	7.29 units on a scale Standard Error 0.17
Change of Generic Qi Score (GQS) Determined by a Standardized Assessment Visit 5	7.65 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	All Participants n=29 Participants 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).
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Baseline · Non-GQD	4 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Baseline · GQD	25 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit2 · Non-GQD	4 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit2 · GQD	25 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit3 · Non-GQD	8 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit3 · GQD	21 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit4 · Non-GQD	9 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit4 · GQD	20 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit5 · Non-GQD	19 Participants
Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment Visit5 · GQD	10 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Junqiang Tian

USANA Health Science

Phone: 8019547462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place