Trial Outcomes & Findings for An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation (NCT NCT00741936)
NCT ID: NCT00741936
Last Updated: 2016-06-24
Results Overview
Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be 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
120 participants
Primary outcome timeframe
End of treatment (wk10)
Results posted on
2016-06-24
Participant Flow
All constipated patients (aged 18-65 years) who presented to the Chinese medicine clinics of the School of Chinese Medicine, Hong Kong Baptist University were referred. In total, 456 patients with constipation were screened from July 2008 to September 2009; of these 120 were randomized into MZRW or placebo group.
Many patients were excluded because they did not fulfill the inclusion criteria or they met the exclusion criteria. The demographic data and baseline variables of participants were comparable among groups
Participant milestones
| Measure |
MaZiRenWan (MZRW)
MZRW granule, 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.
|
Placebo
Placebo granule, 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
|
60
|
60
|
|
Overall Study
COMPLETED
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
MaZiRenWan (MZRW)
MZRW granule, 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.
|
Placebo
Placebo granule, 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
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Low compliance
|
3
|
0
|
Baseline Characteristics
An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Baseline characteristics by cohort
| Measure |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.72 years
STANDARD_DEVIATION 10.62 • n=99 Participants
|
37.53 years
STANDARD_DEVIATION 11.42 • n=107 Participants
|
37.13 years
STANDARD_DEVIATION 10.99 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Duration of constipation
|
13.50 years
STANDARD_DEVIATION 9.96 • n=99 Participants
|
15.25 years
STANDARD_DEVIATION 10.82 • n=107 Participants
|
14.38 years
STANDARD_DEVIATION 10.39 • n=206 Participants
|
|
Bowel movement
|
2.79 movements per week
STANDARD_DEVIATION 1.26 • n=99 Participants
|
3.31 movements per week
STANDARD_DEVIATION 1.61 • n=107 Participants
|
3.05 movements per week
STANDARD_DEVIATION 1.46 • n=206 Participants
|
|
Complete spontaneous bowel movement (CSBM)
|
0.33 movements per week
STANDARD_DEVIATION 0.66 • n=99 Participants
|
0.52 movements per week
STANDARD_DEVIATION 0.69 • n=107 Participants
|
0.42 movements per week
STANDARD_DEVIATION 0.68 • n=206 Participants
|
|
No. of days taking rescue therapy
|
0.93 days per week
STANDARD_DEVIATION 0.17 • n=99 Participants
|
0.84 days per week
STANDARD_DEVIATION 0.15 • n=107 Participants
|
0.89 days per week
STANDARD_DEVIATION 1.24 • n=206 Participants
|
|
Severity of constipation
|
4.47 Units on a scale
STANDARD_DEVIATION 0.102 • n=99 Participants
|
4.40 Units on a scale
STANDARD_DEVIATION 0.10 • n=107 Participants
|
4.43 Units on a scale
STANDARD_DEVIATION 0.76 • n=206 Participants
|
PRIMARY outcome
Timeframe: End of treatment (wk10)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.
Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be 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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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 of Complete Spontaneous Bowel Movement (CSBM)
Non-responder
|
34 participants
|
55 participants
|
|
Responder of Complete Spontaneous Bowel Movement (CSBM)
Responder
|
26 participants
|
5 participants
|
SECONDARY outcome
Timeframe: End of follow up (wk18)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.
Participants with a mean increase of complete spontaneous bowel movement (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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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 of Complete Spontaneous Bowel Movement (CSBM)
Responder
|
18 participants
|
9 participants
|
|
Responder of Complete Spontaneous Bowel Movement (CSBM)
Non-responder
|
42 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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
Baseline(Wk1&2)
|
2.79 movements per week
Standard Deviation 1.26 • Interval 2.47 to 3.12
|
3.31 movements per week
Standard Deviation 1.61 • Interval 2.89 to 3.72
|
|
Bowel Movement
Within treatment(Wk3-10)
|
4.72 movements per week
Standard Deviation 2.37 • Interval 4.11 to 5.33
|
3.73 movements per week
Standard Deviation 1.54 • Interval 3.33 to 4.13
|
|
Bowel Movement
Within follow-up(Wk11-18)
|
3.65 movements per week
Standard Deviation 2.23 • Interval 3.08 to 4.23
|
3.61 movements per week
Standard Deviation 1.61 • Interval 3.2 to 4.03
|
SECONDARY outcome
Timeframe: Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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)
Baseline (Wk1&2)
|
0.33 movements per week
Standard Deviation 0.66 • Interval 0.16 to 0.49
|
0.52 movements per week
Standard Deviation 0.69 • Interval 0.34 to 0.69
|
|
Complete Spontaneous Bowel Movement (CSBM)
Within treatment(Wk3-10)
|
1.62 movements per week
Standard Deviation 1.98 • Interval 1.11 to 2.13
|
0.72 movements per week
Standard Deviation 1.08 • Interval 0.44 to 1.0
|
|
Complete Spontaneous Bowel Movement (CSBM)
Within follow-up (Wk11-18)
|
1.06 movements per week
Standard Deviation 1.67 • Interval 0.62 to 1.49
|
0.75 movements per week
Standard Deviation 1.18 • Interval 0.44 to 1.05
|
SECONDARY outcome
Timeframe: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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.
|
|---|---|---|
|
Changes on Individual Symptom Scores
Severity of constipation (Baseline)
|
4.47 Units on a scale
Standard Deviation 0.79 • Interval 4.26 to 4.67
|
4.40 Units on a scale
Standard Deviation 0.74 • Interval 4.21 to 4.59
|
|
Changes on Individual Symptom Scores
Severity of constipation (Wk6)
|
2.82 Units on a scale
Standard Deviation 1.52 • Interval 2.42 to 3.21
|
3.70 Units on a scale
Standard Deviation 1.49 • Interval 3.32 to 4.08
|
|
Changes on Individual Symptom Scores
Severity of constipation (Wk10)
|
2.93 Units on a scale
Standard Deviation 1.43 • Interval 2.57 to 3.3
|
3.47 Units on a scale
Standard Deviation 1.36 • Interval 3.12 to 3.82
|
|
Changes on Individual Symptom Scores
Severity of constipation (Wk18)
|
3.57 Units on a scale
Standard Deviation 1.47 • Interval 3.19 to 3.95
|
3.63 Units on a scale
Standard Deviation 1.39 • Interval 3.27 to 3.99
|
|
Changes on Individual Symptom Scores
Sensation of straining (Baseline)
|
4.20 Units on a scale
Standard Deviation 0.84 • Interval 3.98 to 4.42
|
3.82 Units on a scale
Standard Deviation 1.20 • Interval 3.51 to 4.13
|
|
Changes on Individual Symptom Scores
Sensation of straining (Wk6)
|
2.60 Units on a scale
Standard Deviation 1.43 • Interval 2.23 to 2.97
|
3.12 Units on a scale
Standard Deviation 1.35 • Interval 2.77 to 3.47
|
|
Changes on Individual Symptom Scores
Sensation of straining (Wk10)
|
2.55 Units on a scale
Standard Deviation 1.52 • Interval 2.16 to 2.94
|
3.28 Units on a scale
Standard Deviation 1.46 • Interval 2.91 to 3.66
|
|
Changes on Individual Symptom Scores
Sensation of straining (Wk18)
|
3.33 Units on a scale
Standard Deviation 1.28 • Interval 3.0 to 3.67
|
3.32 Units on a scale
Standard Deviation 1.37 • Interval 2.96 to 3.67
|
|
Changes on Individual Symptom Scores
Incomplete of evacuation (Baseline)
|
4.40 Units on a scale
Standard Deviation 1.12 • Interval 4.11 to 4.69
|
4.07 Units on a scale
Standard Deviation 1.22 • Interval 3.75 to 4.38
|
|
Changes on Individual Symptom Scores
Incomplete of evacuation (Wk6)
|
3.18 Units on a scale
Standard Deviation 1.40 • Interval 2.82 to 3.54
|
3.47 Units on a scale
Standard Deviation 1.49 • Interval 3.08 to 3.85
|
|
Changes on Individual Symptom Scores
Incomplete of evacuation (Wk10)
|
3.02 Units on a scale
Standard Deviation 1.51 • Interval 2.63 to 3.41
|
3.45 Units on a scale
Standard Deviation 1.55 • Interval 3.05 to 3.85
|
|
Changes on Individual Symptom Scores
Incomplete of evacuation (Wk18)
|
3.62 Units on a scale
Standard Deviation 1.29 • Interval 3.28 to 3.95
|
3.43 Units on a scale
Standard Deviation 1.57 • Interval 3.03 to 3.84
|
|
Changes on Individual Symptom Scores
Sensation of bloating (Baseline)
|
3.62 Units on a scale
Standard Deviation 1.30 • Interval 3.28 to 3.95
|
3.47 Units on a scale
Standard Deviation 1.33 • Interval 3.12 to 3.81
|
|
Changes on Individual Symptom Scores
Sensation of bloating (Wk6)
|
2.53 Units on a scale
Standard Deviation 1.68 • Interval 2.1 to 2.97
|
2.82 Units on a scale
Standard Deviation 1.76 • Interval 2.36 to 3.27
|
|
Changes on Individual Symptom Scores
Sensation of bloating (Wk10)
|
2.23 Units on a scale
Standard Deviation 1.65 • Interval 1.81 to 2.66
|
2.70 Units on a scale
Standard Deviation 1.81 • Interval 2.23 to 3.17
|
|
Changes on Individual Symptom Scores
Sensation of bloating (Wk18)
|
2.92 Units on a scale
Standard Deviation 1.67 • Interval 2.49 to 3.35
|
2.65 Units on a scale
Standard Deviation 1.83 • Interval 2.18 to 3.12
|
|
Changes on Individual Symptom Scores
Sensation of abdominal pain/cramping (Baseline)
|
1.98 Units on a scale
Standard Deviation 1.76 • Interval 1.53 to 2.44
|
1.43 Units on a scale
Standard Deviation 1.58 • Interval 1.03 to 1.84
|
|
Changes on Individual Symptom Scores
Sensation of abdominal pain/cramping (Wk6)
|
1.80 Units on a scale
Standard Deviation 1.60 • Interval 1.39 to 2.21
|
1.12 Units on a scale
Standard Deviation 1.42 • Interval 0.75 to 1.48
|
|
Changes on Individual Symptom Scores
Sensation of abdominal pain/cramping (Wk10)
|
1.22 Units on a scale
Standard Deviation 1.28 • Interval 0.89 to 1.55
|
1.07 Units on a scale
Standard Deviation 1.47 • Interval 0.69 to 1.45
|
|
Changes on Individual Symptom Scores
Sensation of abdominal pain/cramping (Wk18)
|
1.50 Units on a scale
Standard Deviation 1.54 • Interval 1.1 to 1.9
|
0.82 Units on a scale
Standard Deviation 1.35 • Interval 0.47 to 1.16
|
|
Changes on Individual Symptom Scores
Sensation of nausea (Baseline)
|
1.00 Units on a scale
Standard Deviation 1.54 • Interval 0.6 to 1.4
|
0.83 Units on a scale
Standard Deviation 1.45 • Interval 0.46 to 1.21
|
|
Changes on Individual Symptom Scores
Sensation of nausea (Wk6)
|
0.68 Units on a scale
Standard Deviation 1.21 • Interval 0.37 to 1.0
|
1.03 Units on a scale
Standard Deviation 1.57 • Interval 0.63 to 1.44
|
|
Changes on Individual Symptom Scores
Sensation of nausea (Wk10)
|
0.53 Units on a scale
Standard Deviation 0.97 • Interval 0.28 to 0.78
|
0.78 Units on a scale
Standard Deviation 1.30 • Interval 0.45 to 1.12
|
|
Changes on Individual Symptom Scores
Sensation of nausea (Wk18)
|
0.97 Units on a scale
Standard Deviation 1.48 • Interval 0.58 to 1.35
|
0.73 Units on a scale
Standard Deviation 1.53 • Interval 0.34 to 1.13
|
|
Changes on Individual Symptom Scores
Passing of gas (Baseline)
|
2.93 Units on a scale
Standard Deviation 1.75 • Interval 2.48 to 3.38
|
2.97 Units on a scale
Standard Deviation 1.67 • Interval 2.54 to 3.4
|
|
Changes on Individual Symptom Scores
Passing of gas (Wk6)
|
2.73 Units on a scale
Standard Deviation 1.52 • Interval 2.34 to 3.13
|
2.53 Units on a scale
Standard Deviation 1.70 • Interval 2.09 to 2.97
|
|
Changes on Individual Symptom Scores
Passing of gas (Wk10)
|
2.55 Units on a scale
Standard Deviation 1.43 • Interval 2.18 to 2.92
|
2.27 Units on a scale
Standard Deviation 1.68 • Interval 1.83 to 2.7
|
|
Changes on Individual Symptom Scores
Passing of gas (Wk18)
|
2.73 Units on a scale
Standard Deviation 1.46 • Interval 2.36 to 3.11
|
2.40 Units on a scale
Standard Deviation 1.60 • Interval 1.99 to 2.81
|
SECONDARY outcome
Timeframe: Wk 6, 10 & wk 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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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
Improved (Wk6)
|
49 participants
|
28 participants
|
|
Global Symptoms Improvement
Same (Wk6)
|
11 participants
|
27 participants
|
|
Global Symptoms Improvement
Worse (Wk6)
|
0 participants
|
5 participants
|
|
Global Symptoms Improvement
Improved (Wk10)
|
48 participants
|
32 participants
|
|
Global Symptoms Improvement
Same (Wk10)
|
12 participants
|
24 participants
|
|
Global Symptoms Improvement
Worse (Wk10)
|
0 participants
|
4 participants
|
|
Global Symptoms Improvement
Improved (Wk18)
|
30 participants
|
31 participants
|
|
Global Symptoms Improvement
Same (Wk18)
|
25 participants
|
27 participants
|
|
Global Symptoms Improvement
Worse (Wk18)
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: End of follow-up (Wk18)Population: Only for subjects attended the last follow-up visit on Wk 18.
The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.
Outcome measures
| Measure |
MaZiRenWan (MZRW)
n=54 No. of subjects attended last visit
MZRW granule, 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.
|
Placebo
n=55 No. of subjects attended last visit
Placebo granule, 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.
|
|---|---|---|
|
Success of Blinding
Subjects with correct guessing
|
32 participants
|
16 participants
|
|
Success of Blinding
Investigator with correct guessing
|
42 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Pre-treatment (Wk2) & Post-treatment (Wk10)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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
Pre-treatment (Wk2)
|
3.87 mmol/L
Standard Deviation 1.03
|
3.98 mmol/L
Standard Deviation 0.93
|
|
Blood Urea Level
Post-treatment (Wk10)
|
4.01 mmol/L
Standard Deviation 0.97
|
4.24 mmol/L
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Pre-treatment (Wk2) & Post-treatment (Wk10)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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
Pre-treatment (Wk2)
|
66.67 μmol/L
Standard Deviation 9.48
|
66.05 μmol/L
Standard Deviation 7.91
|
|
Blood Creatinine Level
Post-treatment (Wk10)
|
66.90 μmol/L
Standard Deviation 9.20
|
64.62 μmol/L
Standard Deviation 7.40
|
SECONDARY outcome
Timeframe: Pre-treatment (Wk2) & Post-treatment (Wk10)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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
Pre-treatment (Wk2)
|
15.82 U/L
Standard Deviation 7.81
|
14.05 U/L
Standard Deviation 4.87
|
|
Serum Glutamic Pyruvic Transaminase(SGPT) Level
Post-treatment (Wk10)
|
14.70 U/L
Standard Deviation 5.50
|
13.68 U/L
Standard Deviation 4.55
|
SECONDARY outcome
Timeframe: Pre-treatment (Wk2) & Post-treatment (Wk10)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 |
MaZiRenWan (MZRW)
n=60 Participants
MZRW granule, 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.
|
Placebo
n=60 Participants
Placebo granule, 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)
Pre-treatment (Wk2)
|
17.82 U/L
Standard Deviation 4.05
|
17.77 U/L
Standard Deviation 3.91
|
|
Serum Glutamic Oxaloacetic Transaminase (SGOT)
Post-treatment (Wk10)
|
17.20 U/L
Standard Deviation 3.45
|
17.12 U/L
Standard Deviation 4.27
|
Adverse Events
MaZiRenWan (MZRW)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MaZiRenWan (MZRW)
n=60 participants at risk
MZRW granule, 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.
|
Placebo
n=60 participants at risk
Placebo granule, 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
|
13.3%
8/60 • Within the whole 18 weeks study period
|
3.3%
2/60 • Within the whole 18 weeks study period
|
|
Gastrointestinal disorders
nausea or stomach discomfort
|
6.7%
4/60 • Within the whole 18 weeks study period
|
6.7%
4/60 • Within the whole 18 weeks study period
|
|
Gastrointestinal disorders
diarrhea and passing of gas
|
1.7%
1/60 • Within the whole 18 weeks study period
|
0.00%
0/60 • Within the whole 18 weeks study period
|
|
General disorders
dizziness or headache
|
1.7%
1/60 • Within the whole 18 weeks study period
|
3.3%
2/60 • Within the whole 18 weeks study period
|
|
General disorders
palpitations and trembling hands
|
0.00%
0/60 • Within the whole 18 weeks study period
|
1.7%
1/60 • Within the whole 18 weeks study period
|
|
Renal and urinary disorders
difficulty in micturition
|
1.7%
1/60 • Within the whole 18 weeks study period
|
0.00%
0/60 • Within the whole 18 weeks study period
|
|
General disorders
aggravation of rhinitis symptoms
|
1.7%
1/60 • Within the whole 18 weeks study period
|
0.00%
0/60 • Within the whole 18 weeks study period
|
|
General disorders
skin itching
|
0.00%
0/60 • Within the whole 18 weeks study period
|
1.7%
1/60 • Within the whole 18 weeks study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place