Trial Outcomes & Findings for RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19 (NCT NCT04939415)
NCT ID: NCT04939415
Last Updated: 2025-09-05
Results Overview
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
COMPLETED
PHASE1
60 participants
14 days
2025-09-05
Participant Flow
Participant milestones
| Measure |
Modified Qing Fei Pei Du Tang
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Modified Qing Fei Pei Du Tang
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
APTT values were not available for all subjects.
Baseline characteristics by cohort
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 13.5 • n=24 Participants
|
43.0 years
STANDARD_DEVIATION 14.0 • n=23 Participants
|
44.13 years
STANDARD_DEVIATION 13.67 • n=47 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=24 Participants
|
16 Participants
n=23 Participants
|
34 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
13 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
16 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=24 Participants
|
16 Participants
n=23 Participants
|
31 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=24 Participants
|
21 Participants
n=23 Participants
|
39 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=47 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
47 Participants
n=47 Participants
|
|
Total Protein Normal
|
22 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
44 Participants
n=47 Participants
|
|
Albumin Normal
|
22 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
44 Participants
n=47 Participants
|
|
Alkaline Phosphatase Normal
|
23 Participants
n=24 Participants
|
21 Participants
n=23 Participants
|
44 Participants
n=47 Participants
|
|
AST Normal
|
21 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
43 Participants
n=47 Participants
|
|
ALT Normal
|
21 Participants
n=24 Participants
|
21 Participants
n=23 Participants
|
42 Participants
n=47 Participants
|
|
Total Bilirubin Normal
|
24 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
47 Participants
n=47 Participants
|
|
eGFR Normal
|
20 Participants
n=24 Participants
|
20 Participants
n=23 Participants
|
40 Participants
n=47 Participants
|
|
Prothrombin Time Normal
|
14 Participants
n=24 Participants
|
18 Participants
n=23 Participants
|
32 Participants
n=47 Participants
|
|
APTT Normal
|
21 Participants
n=23 Participants • APTT values were not available for all subjects.
|
16 Participants
n=22 Participants • APTT values were not available for all subjects.
|
37 Participants
n=45 Participants • APTT values were not available for all subjects.
|
|
ESR Normal
|
11 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
23 Participants
n=47 Participants
|
|
CRP Normal
|
14 Participants
n=22 Participants • CRP values were not available for all participants.
|
12 Participants
n=23 Participants • CRP values were not available for all participants.
|
26 Participants
n=45 Participants • CRP values were not available for all participants.
|
|
LDH Normal
|
10 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
22 Participants
n=47 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=22 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=22 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Total Protein Normal to Abnormal Transition
|
4.5 percentage of participants
|
4.6 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=22 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=22 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Albumin Normal to Abnormal Transition
|
4.5 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=23 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=21 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Alkaline Phosphatase Normal to Abnormal Transition
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=21 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=22 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
AST Normal to Abnormal Transition
|
4.8 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=21 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=21 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
ALT Normal to Abnormal Transition
|
9.5 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Bilirubin Normal to Abnormal Transition
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=20 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=20 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Adj. EGFR Normal to Abnormal Transition
|
15.0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=14 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=18 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Prothrombin Time Normal to Abnormal Transition
|
7.1 percentage of participants
|
5.6 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=21 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=16 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
APTT Normal to Abnormal Transition
|
9.5 percentage of participants
|
12.5 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=11 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=12 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
ESR Normal to Abnormal Transition
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded. Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=14 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=12 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
CRP Normal to Abnormal Transition
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups.
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=10 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=12 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
LDH Normal to Abnormal Transition
|
50 percentage of participants
|
41.7 percentage of participants
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 7 and 14.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Mid-turbinate SARS CoV-2 Viral Load
Baseline (Day 1)
|
17.9358 copies per mL
Standard Deviation 7.07254
|
15.5282 copies per mL
Standard Deviation 6.19859
|
|
Mid-turbinate SARS CoV-2 Viral Load
Day 7
|
33.9909 copies per mL
Standard Deviation 8.67777
|
32.7374 copies per mL
Standard Deviation 8.62281
|
|
Mid-turbinate SARS CoV-2 Viral Load
Day 14
|
37.5100 copies per mL
Standard Deviation 5.05021
|
35.8814 copies per mL
Standard Deviation 6.33340
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Albumin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Albumin
Baseline (Day 1)
|
4.43 U/L
Standard Deviation 0.38
|
4.5 U/L
Standard Deviation 0.22
|
|
Albumin
Day 14
|
4.49 U/L
Standard Deviation 0.37
|
4.56 U/L
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Alkaline Phosphatase
Baseline (Day 1)
|
83.96 U/L
Standard Deviation 52.27
|
78.83 U/L
Standard Deviation 24.03
|
|
Alkaline Phosphatase
Day 14
|
79.71 U/L
Standard Deviation 26.31
|
75.32 U/L
Standard Deviation 21.12
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the AST of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
AST
Baseline (Day 1)
|
28.54 U/L
Standard Deviation 16.72
|
21.00 U/L
Standard Deviation 7.32
|
|
AST
Day 14
|
25.88 U/L
Standard Deviation 10.84
|
17.91 U/L
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ALT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
ALT
Baseline (Day 1)
|
28.46 U/L
Standard Deviation 16.64
|
23.78 U/L
Standard Deviation 17.18
|
|
ALT
Day 14
|
29.46 U/L
Standard Deviation 17.73
|
19.41 U/L
Standard Deviation 8.38
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Total Bilirubin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Total Bilirubin
Baseline (Day 1)
|
0.39 mg/dL
Standard Deviation 0.20
|
0.41 mg/dL
Standard Deviation 0.20
|
|
Total Bilirubin
Day 14
|
0.52 mg/dL
Standard Deviation 0.20
|
0.42 mg/dL
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Adj. EGFR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Adj. EGFR
Baseline (Day 1)
|
111.25 mL/min
Standard Deviation 24.90
|
117.09 mL/min
Standard Deviation 26.97
|
|
Adj. EGFR
Day 14
|
107.65 mL/min
Standard Deviation 22.82
|
114.16 mL/min
Standard Deviation 27.72
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Prothrombin Time of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Prothrombin Time
Baseline (Day 1)
|
11.88 sec
Standard Deviation 1.12
|
11.66 sec
Standard Deviation 1.15
|
|
Prothrombin Time
Day 14
|
11.9 sec
Standard Deviation 1.02
|
11.28 sec
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the APTT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
APTT
Baseline (Day 1)
|
32.85 sec
Standard Deviation 6.01
|
33.37 sec
Standard Deviation 2.93
|
|
APTT
Day 14
|
32.24 sec
Standard Deviation 5.34
|
32.36 sec
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the INR (international normalized ratio) of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). The INR is a result of a blood test that measures how long it takes for blood to clot, also known as the prothrombin time (PT). The INR is calculated by comparing the PT to the mean normal prothrombin time (MNPT). Higher INR is thought to indicate liver dysfunction.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
INR
Baseline (Day 1)
|
1.06 ratio
Standard Deviation 0.10
|
1.1 ratio
Standard Deviation 0.11
|
|
INR
Day 14
|
1.07 ratio
Standard Deviation 0.08
|
1.07 ratio
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ESR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
ESR
Baseline (Day 1)
|
16.18 mm/hr
Standard Deviation 11.56
|
18.80 mm/hr
Standard Deviation 12.89
|
|
ESR
Day 14
|
12.50 mm/hr
Standard Deviation 9.07
|
15.62 mm/hr
Standard Deviation 17.19
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the CRP of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
CRP
Baseline (Day 1)
|
1.87 mg/dL
Standard Deviation 5.01
|
0.88 mg/dL
Standard Deviation 1.02
|
|
CRP
Day 14
|
1.10 mg/dL
Standard Deviation 2.85
|
0.35 mg/dL
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 14 daysA secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the LDH of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
LDH
Day 14
|
210.29 U/L
Standard Deviation 58.62
|
186.59 U/L
Standard Deviation 24.68
|
|
LDH
Baseline (Day 1)
|
208.5 U/L
Standard Deviation 80.95
|
177.48 U/L
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: 14 daysSymptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and counting the total number of symptoms present.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Symptom Count
Baseline (Day 0)
|
8.3750 Total Number of Symptoms
Standard Deviation 2.01759
|
7.3043 Total Number of Symptoms
Standard Deviation 2.49426
|
|
Symptom Count
Day 1
|
7.5000 Total Number of Symptoms
Standard Deviation 2.82843
|
5.7826 Total Number of Symptoms
Standard Deviation 3.19028
|
|
Symptom Count
Day 2
|
6.6667 Total Number of Symptoms
Standard Deviation 2.35292
|
6.0435 Total Number of Symptoms
Standard Deviation 2.24577
|
|
Symptom Count
Day 3
|
6.3750 Total Number of Symptoms
Standard Deviation 2.65088
|
5.6522 Total Number of Symptoms
Standard Deviation 2.32787
|
|
Symptom Count
Day 4
|
5.6667 Total Number of Symptoms
Standard Deviation 2.89928
|
5.1739 Total Number of Symptoms
Standard Deviation 2.53435
|
|
Symptom Count
Day 5
|
5.3333 Total Number of Symptoms
Standard Deviation 2.85393
|
4.3043 Total Number of Symptoms
Standard Deviation 2.94549
|
|
Symptom Count
Day 6
|
4.5000 Total Number of Symptoms
Standard Deviation 2.70266
|
3.9565 Total Number of Symptoms
Standard Deviation 2.93069
|
|
Symptom Count
Day 7
|
4.5000 Total Number of Symptoms
Standard Deviation 2.53669
|
3.3043 Total Number of Symptoms
Standard Deviation 3.05160
|
|
Symptom Count
Day 8
|
4.0833 Total Number of Symptoms
Standard Deviation 2.73332
|
2.9565 Total Number of Symptoms
Standard Deviation 2.63677
|
|
Symptom Count
Day 9
|
3.9583 Total Number of Symptoms
Standard Deviation 2.85107
|
2.6522 Total Number of Symptoms
Standard Deviation 2.44222
|
|
Symptom Count
Day 10
|
3.6667 Total Number of Symptoms
Standard Deviation 2.72934
|
2.3043 Total Number of Symptoms
Standard Deviation 2.26505
|
|
Symptom Count
Day 11
|
3.2083 Total Number of Symptoms
Standard Deviation 2.35869
|
1.9545 Total Number of Symptoms
Standard Deviation 2.05814
|
|
Symptom Count
Day 12
|
2.5417 Total Number of Symptoms
Standard Deviation 2.50181
|
1.6364 Total Number of Symptoms
Standard Deviation 2.03646
|
|
Symptom Count
Day 13
|
2.6250 Total Number of Symptoms
Standard Deviation 2.46387
|
1.6818 Total Number of Symptoms
Standard Deviation 1.83579
|
|
Symptom Count
Day 14
|
2.3750 Total Number of Symptoms
Standard Deviation 2.49891
|
1.8182 Total Number of Symptoms
Standard Deviation 1.96726
|
SECONDARY outcome
Timeframe: 14 daysSymptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache) by summing the total symptom severities for those symptoms. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 30, respectively.
Outcome measures
| Measure |
Modified Qing Fei Pei Du Tang
n=24 Participants
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 Participants
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Symptom Severities
Baseline (Day 0)
|
16.0000 units on a scale
Standard Deviation 6.13614
|
15.5217 units on a scale
Standard Deviation 7.21658
|
|
Symptom Severities
Day 1
|
14.0417 units on a scale
Standard Deviation 6.81736
|
11.0455 units on a scale
Standard Deviation 6.26766
|
|
Symptom Severities
Day 2
|
12.2500 units on a scale
Standard Deviation 6.26411
|
10.0000 units on a scale
Standard Deviation 4.98179
|
|
Symptom Severities
Day 3
|
11.9583 units on a scale
Standard Deviation 6.86186
|
8.6087 units on a scale
Standard Deviation 4.09811
|
|
Symptom Severities
Day 4
|
10.1667 units on a scale
Standard Deviation 6.58501
|
7.7826 units on a scale
Standard Deviation 4.79542
|
|
Symptom Severities
Day 5
|
9.1667 units on a scale
Standard Deviation 5.89522
|
6.0000 units on a scale
Standard Deviation 5.03623
|
|
Symptom Severities
Day 6
|
7.5417 units on a scale
Standard Deviation 5.48499
|
5.3913 units on a scale
Standard Deviation 4.39772
|
|
Symptom Severities
Day 7
|
7.0417 units on a scale
Standard Deviation 5.05173
|
4.6087 units on a scale
Standard Deviation 4.56009
|
|
Symptom Severities
Day 8
|
6.3333 units on a scale
Standard Deviation 5.28054
|
3.9565 units on a scale
Standard Deviation 4.17218
|
|
Symptom Severities
Day 9
|
6.2500 units on a scale
Standard Deviation 5.78040
|
3.6522 units on a scale
Standard Deviation 3.92670
|
|
Symptom Severities
Day 10
|
5.7917 units on a scale
Standard Deviation 5.70262
|
3.0870 units on a scale
Standard Deviation 3.08829
|
|
Symptom Severities
Day 11
|
5.1667 units on a scale
Standard Deviation 6.23919
|
2.4545 units on a scale
Standard Deviation 2.72077
|
|
Symptom Severities
Day 12
|
4.0000 units on a scale
Standard Deviation 6.00000
|
1.9545 units on a scale
Standard Deviation 2.57233
|
|
Symptom Severities
Day 13
|
4.2083 units on a scale
Standard Deviation 5.51661
|
2.0000 units on a scale
Standard Deviation 2.39046
|
|
Symptom Severities
Day 14
|
4.0417 units on a scale
Standard Deviation 6.01071
|
2.1364 units on a scale
Standard Deviation 2.41613
|
Adverse Events
Modified Qing Fei Pei Du Tang
Placebo
Serious adverse events
| Measure |
Modified Qing Fei Pei Du Tang
n=24 participants at risk
encapsulated modified Qing Fei Pai Du Tang
mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
Placebo
n=23 participants at risk
Organic brown rice
organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
|
|---|---|---|
|
Gastrointestinal disorders
ER visit
|
4.2%
1/24 • Number of events 1 • 14 days
|
0.00%
0/23 • 14 days
|
|
General disorders
ER Visit
|
4.2%
1/24 • Number of events 1 • 14 days
|
0.00%
0/23 • 14 days
|
Other adverse events
Adverse event data not reported
Additional Information
Gordon Saxe, M.D./Ph.D.
Krupp Center for Integrative Research, University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place