Trial Outcomes & Findings for A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation (NCT NCT00299975)
NCT ID: NCT00299975
Last Updated: 2015-04-24
Results Overview
Participants with a mean increase of CSBM\>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Week3-10
Results posted on
2015-04-24
Participant Flow
All constipated patients (aged 18-65) who presented to the Chinese Medicine Clinics of School of Chinese Medicine, Hong Kong Baptist University from October 2006 to May 2007 were refered.
177 patients were screened; of these 80 patients were excluded due to not meeting inclusion criteria (68 cases), refused to participate (6 cases) and lost to follow up (6 cases).
Participant milestones
| Measure |
Low Dose Group
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
33
|
|
Overall Study
Received Allocated Intervention
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
29
|
31
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
8
|
Reasons for withdrawal
| Measure |
Low Dose Group
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Baseline characteristics by cohort
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Duration of constipation
|
10.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
13.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
15.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Bowel Movement
|
3.6 movements per week
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.1 movements per week
STANDARD_DEVIATION 1.4 • n=7 Participants
|
4.7 movements per week
STANDARD_DEVIATION 4.1 • n=5 Participants
|
3.8 movements per week
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Complete Spontaneous Bowel Movement (CSBM)
|
0.5 movements per week
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.5 movements per week
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.5 movements per week
STANDARD_DEVIATION 0.7 • n=5 Participants
|
0.5 movements per week
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
No. of days taking rescue therapy
|
1.7 days per week
STANDARD_DEVIATION 2.8 • n=5 Participants
|
2.4 days per week
STANDARD_DEVIATION 3.3 • n=7 Participants
|
2.2 days per week
STANDARD_DEVIATION 3.2 • n=5 Participants
|
2.1 days per week
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Severity of Constipation
|
4.2 Units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.1 Units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
4.3 Units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
4.2 Units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week3-10Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Participants with a mean increase of CSBM\>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Responder for Complete Spontaneous Bowel Movement (CSBM)
Responder
|
10 participants
|
14 participants
|
17 participants
|
|
Responder for Complete Spontaneous Bowel Movement (CSBM)
Non-responder
|
22 participants
|
18 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Week11-18Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Participants with a mean increase of CSBM\>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Responder for Complete Spontaneous Bowel Movement (CSBM)
Responder
|
9 participants
|
10 participants
|
11 participants
|
|
Responder for Complete Spontaneous Bowel Movement (CSBM)
Non-responder
|
23 participants
|
22 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Bowel Movement
Wk1-2
|
3.6 movements per week
Standard Deviation 1.5
|
3.1 movements per week
Standard Deviation 1.4
|
4.7 movements per week
Standard Deviation 4.1
|
|
Bowel Movement
Wk3-10
|
4.2 movements per week
Standard Deviation 1.7
|
4.8 movements per week
Standard Deviation 1.8
|
6.5 movements per week
Standard Deviation 5.5
|
|
Bowel Movement
Wk11-18
|
3.9 movements per week
Standard Deviation 1.6
|
3.5 movements per week
Standard Deviation 1.2
|
5.2 movements per week
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM)
Week11-18
|
1.4 movements per week
Standard Deviation 1.5
|
1.0 movements per week
Standard Deviation 1.2
|
1.3 movements per week
Standard Deviation 1.6
|
|
Complete Spontaneous Bowel Movement (CSBM)
Week1-2
|
0.5 movements per week
Standard Deviation 0.6
|
0.5 movements per week
Standard Deviation 0.7
|
0.5 movements per week
Standard Deviation 0.7
|
|
Complete Spontaneous Bowel Movement (CSBM)
Week3-10
|
1.4 movements per week
Standard Deviation 1.4
|
1.6 movements per week
Standard Deviation 1.5
|
2.0 movements per week
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week6, 10 & 18Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Global Symptoms Improvement
Week6-Worse
|
3 participants
|
1 participants
|
2 participants
|
|
Global Symptoms Improvement
Week18-Improved
|
20 participants
|
14 participants
|
20 participants
|
|
Global Symptoms Improvement
Week18-Same
|
11 participants
|
14 participants
|
12 participants
|
|
Global Symptoms Improvement
Week6-Improved
|
25 participants
|
24 participants
|
26 participants
|
|
Global Symptoms Improvement
Week6-Same
|
4 participants
|
7 participants
|
4 participants
|
|
Global Symptoms Improvement
Week10-Improved
|
20 participants
|
27 participants
|
24 participants
|
|
Global Symptoms Improvement
Week10-Same
|
10 participants
|
5 participants
|
6 participants
|
|
Global Symptoms Improvement
Week10-Worse
|
2 participants
|
0 participants
|
2 participants
|
|
Global Symptoms Improvement
Week18-Worse
|
1 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Severity of Constipation
Week2
|
4.22 Units on a scale
Standard Deviation 1.07
|
4.06 Units on a scale
Standard Deviation 1.32
|
4.25 Units on a scale
Standard Deviation 1.46
|
|
Severity of Constipation
Week6
|
2.72 Units on a scale
Standard Deviation 1.87
|
2.03 Units on a scale
Standard Deviation 1.84
|
2.03 Units on a scale
Standard Deviation 1.75
|
|
Severity of Constipation
Week10
|
2.62 Units on a scale
Standard Deviation 1.88
|
2.06 Units on a scale
Standard Deviation 1.76
|
2.06 Units on a scale
Standard Deviation 1.81
|
|
Severity of Constipation
Week18
|
3.03 Units on a scale
Standard Deviation 1.91
|
2.91 Units on a scale
Standard Deviation 1.92
|
2.38 Units on a scale
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Sensation of Straining
Week2
|
4.03 Units on a scale
Standard Deviation 1.06
|
3.53 Units on a scale
Standard Deviation 1.61
|
3.78 Units on a scale
Standard Deviation 1.60
|
|
Sensation of Straining
Week6
|
2.62 Units on a scale
Standard Deviation 1.79
|
1.84 Units on a scale
Standard Deviation 1.73
|
2.16 Units on a scale
Standard Deviation 1.61
|
|
Sensation of Straining
Week10
|
2.56 Units on a scale
Standard Deviation 1.92
|
2.06 Units on a scale
Standard Deviation 1.70
|
1.94 Units on a scale
Standard Deviation 1.74
|
|
Sensation of Straining
Week18
|
2.69 Units on a scale
Standard Deviation 1.86
|
2.78 Units on a scale
Standard Deviation 1.88
|
2.34 Units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Incomplete of Evacuation
Week2
|
4.53 Units on a scale
Standard Deviation 1.41
|
3.5 Units on a scale
Standard Deviation 1.63
|
3.97 Units on a scale
Standard Deviation 1.26
|
|
Incomplete of Evacuation
Week6
|
2.81 Units on a scale
Standard Deviation 1.87
|
2.59 Units on a scale
Standard Deviation 1.66
|
2.59 Units on a scale
Standard Deviation 1.58
|
|
Incomplete of Evacuation
Week10
|
2.69 Units on a scale
Standard Deviation 1.91
|
2.63 Units on a scale
Standard Deviation 1.64
|
2.66 Units on a scale
Standard Deviation 1.77
|
|
Incomplete of Evacuation
Week18
|
3.00 Units on a scale
Standard Deviation 1.83
|
2.94 Units on a scale
Standard Deviation 1.70
|
2.50 Units on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Sensation of Bloating
Week2
|
2.53 Units on a scale
Standard Deviation 1.90
|
2.75 Units on a scale
Standard Deviation 1.92
|
3.28 Units on a scale
Standard Deviation 1.87
|
|
Sensation of Bloating
Week6
|
2.03 Units on a scale
Standard Deviation 1.91
|
1.84 Units on a scale
Standard Deviation 1.63
|
1.91 Units on a scale
Standard Deviation 1.82
|
|
Sensation of Bloating
Week10
|
1.78 Units on a scale
Standard Deviation 1.85
|
1.63 Units on a scale
Standard Deviation 1.66
|
1.75 Units on a scale
Standard Deviation 1.92
|
|
Sensation of Bloating
Week18
|
1.91 Units on a scale
Standard Deviation 1.69
|
2.19 Units on a scale
Standard Deviation 1.86
|
1.94 Units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Sensation of Abdominal Pain/Cramping
Week2
|
1.00 Units on a scale
Standard Deviation 1.24
|
1.12 Units on a scale
Standard Deviation 1.29
|
1.59 Units on a scale
Standard Deviation 1.68
|
|
Sensation of Abdominal Pain/Cramping
Week6
|
1.00 Units on a scale
Standard Deviation 1.27
|
1.03 Units on a scale
Standard Deviation 1.31
|
1.50 Units on a scale
Standard Deviation 1.48
|
|
Sensation of Abdominal Pain/Cramping
Week10
|
0.41 Units on a scale
Standard Deviation 0.98
|
1.09 Units on a scale
Standard Deviation 1.20
|
1.47 Units on a scale
Standard Deviation 1.74
|
|
Sensation of Abdominal Pain/Cramping
Week18
|
0.47 Units on a scale
Standard Deviation 0.92
|
0.91 Units on a scale
Standard Deviation 1.25
|
0.84 Units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Passing of Gas
Week2
|
2.37 Units on a scale
Standard Deviation 1.70
|
2.59 Units on a scale
Standard Deviation 1.43
|
3.34 Units on a scale
Standard Deviation 1.29
|
|
Passing of Gas
Week6
|
2.03 Units on a scale
Standard Deviation 1.49
|
1.97 Units on a scale
Standard Deviation 1.49
|
2.44 Units on a scale
Standard Deviation 1.46
|
|
Passing of Gas
Week10
|
1.38 Units on a scale
Standard Deviation 1.24
|
2.06 Units on a scale
Standard Deviation 1.27
|
2.38 Units on a scale
Standard Deviation 1.56
|
|
Passing of Gas
Week18
|
1.25 Units on a scale
Standard Deviation 1.19
|
2.19 Units on a scale
Standard Deviation 1.36
|
2.53 Units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: pre-treatment & post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment(Week2) & Post-treatment(Week10)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Blood Urea Level
Week2
|
4.68 mmol/L
Standard Deviation 1.23
|
4.54 mmol/L
Standard Deviation 1.12
|
4.31 mmol/L
Standard Deviation 1.25
|
|
Blood Urea Level
Week10
|
4.40 mmol/L
Standard Deviation 1.18
|
4.41 mmol/L
Standard Deviation 0.94
|
4.30 mmol/L
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Pre-treatment(Week2) & Post-treatment(Week10)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Blood Creatinine Level
Week2
|
58.81 μmol/L
Standard Deviation 13.22
|
58.00 μmol/L
Standard Deviation 15.23
|
57.38 μmol/L
Standard Deviation 12.46
|
|
Blood Creatinine Level
Week10
|
58.81 μmol/L
Standard Deviation 10.17
|
60.06 μmol/L
Standard Deviation 17.27
|
58.09 μmol/L
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: Pre-treatment(Week2) & Post-treatment(Week10)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Serum Glutamic Pyruvic Transaminase(SGPT) Level
Week2
|
32.38 U/L
Standard Deviation 6.95
|
32.78 U/L
Standard Deviation 5.33
|
34.06 U/L
Standard Deviation 9.01
|
|
Serum Glutamic Pyruvic Transaminase(SGPT) Level
Week10
|
33.44 U/L
Standard Deviation 8.99
|
34.06 U/L
Standard Deviation 6.67
|
34.16 U/L
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: Pre-treatment(Week2) & Post-treatment(Week10)Population: Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.
Outcome measures
| Measure |
Low Dose Group
n=32 Participants
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 Participants
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 Participants
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Serum Glutamic Oxaloacetic Transaminase(SGOT) Level
Week2
|
18.50 U/L
Standard Deviation 5.01
|
18.28 U/L
Standard Deviation 4.30
|
19.44 U/L
Standard Deviation 5.29
|
|
Serum Glutamic Oxaloacetic Transaminase(SGOT) Level
Week10
|
18.69 U/L
Standard Deviation 5.04
|
19.09 U/L
Standard Deviation 5.08
|
19.09 U/L
Standard Deviation 5.57
|
Adverse Events
Low Dose Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Median Dose Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
High Dose Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Group
n=32 participants at risk
MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
Median Dose Group
n=32 participants at risk
MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
High Dose Group
n=32 participants at risk
MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping or bloating
|
21.9%
7/32 • 18 weeks
Within the whole study period
|
21.9%
7/32 • 18 weeks
Within the whole study period
|
25.0%
8/32 • 18 weeks
Within the whole study period
|
|
Gastrointestinal disorders
Upper gastro-intestinal discomfort
|
12.5%
4/32 • 18 weeks
Within the whole study period
|
12.5%
4/32 • 18 weeks
Within the whole study period
|
18.8%
6/32 • 18 weeks
Within the whole study period
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
|
Reproductive system and breast disorders
Disturbance of menstruation
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
|
Skin and subcutaneous tissue disorders
Puffy face
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
|
General disorders
Increase body odor
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
0.00%
0/32 • 18 weeks
Within the whole study period
|
3.1%
1/32 • 18 weeks
Within the whole study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place