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A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZhaoXiang Bian, Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT00299975
First received: March 6, 2006
Last updated: November 14, 2011
Last verified: November 2011
Results First Received: August 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: MaZiRenWan (MZRW) 2.5g/sachet
Drug: MaZiRenWan (MZRW) 5.0g/sachet
Drug: MaZiRenWan (MZRW)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Low Dose Group     Median Dose Group     High Dose Group  
STARTED     32     32     33  
Received Allocated Intervention     32     32     32  
COMPLETED     29     31     25  
NOT COMPLETED     3     1     8  
Adverse Event                 1                 0                 2  
Pregnancy                 0                 0                 1  
Lack of Efficacy                 1                 0                 1  
Lost to Follow-up                 1                 0                 0  
Withdrawal by Subject                 0                 1                 3  
Physician Decision                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Low Dose Group     Median Dose Group     High Dose Group     Total  
Number of Participants  
[units: participants]
  32     32     32     96  
Age  
[units: years]
Mean ± Standard Deviation
  35.5  ± 9.8     38.8  ± 9.9     36.1  ± 9.2     36.8  ± 9.6  
Gender  
[units: participants]
       
Female     30     27     30     87  
Male     2     5     2     9  
Duration of constipation  
[units: years]
Mean ± Standard Deviation
  10.9  ± 8.5     13.7  ± 10.0     15.0  ± 10.9     13.2  ± 9.9  
Bowel Movement  
[units: movements per week]
Mean ± Standard Deviation
  3.6  ± 1.5     3.1  ± 1.4     4.7  ± 4.1     3.8  ± 2.7  
Complete Spontaneous Bowel Movement (CSBM) [1]
[units: movements per week]
Mean ± Standard Deviation
  0.5  ± 0.6     0.5  ± 0.7     0.5  ± 0.7     0.5  ± 0.7  
No. of days taking rescue therapy [2]
[units: days per week]
Mean ± Standard Deviation
  1.7  ± 2.8     2.4  ± 3.3     2.2  ± 3.2     2.1  ± 3.1  
Severity of Constipation [3]
[units: Units on a scale]
Mean ± Standard Deviation
  4.2  ± 1.1     4.1  ± 1.3     4.3  ± 1.5     4.2  ± 1.3  
[1] 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.
[2] Any medications, including laxatives, enemas and Chinese herbal medicine, for facilitating bowel movements.
[3] It was a 7-point ordinal scale from 0=not at all to 6=very severe.



  Outcome Measures
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1.  Primary:   Responder for Complete Spontaneous Bowel Movement (CSBM)   [ Time Frame: Wk3-10 ]

2.  Secondary:   Responder for Complete Spontaneous Bowel Movement (CSBM)   [ Time Frame: WK11-18 ]

3.  Secondary:   Bowel Movement   [ Time Frame: Baseline(Wk1-2), Within treatment(Wk3-10) & Within follow-up(Wk11-18) ]

4.  Secondary:   Complete Spontaneous Bowel Movement (CSBM)   [ Time Frame: Baseline(Wk1-2), Within treatment(Wk3-10) & Within follow-up(Wk11-18) ]

5.  Secondary:   Global Symptoms Improvement   [ Time Frame: WK6, 10 & 18 ]

6.  Secondary:   Severity of Constipation   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]

7.  Secondary:   Sensation of Straining   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]

8.  Secondary:   Incomplete of Evacuation   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Incomplete of Evacuation
Measure Description It was a 7-point ordinal scale from 0=not at all to 6=very severe.
Time Frame Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.

Measured Values
    Low Dose Group     Median Dose Group     High Dose Group  
Number of Participants Analyzed  
[units: participants]
  32     32     32  
Incomplete of Evacuation  
[units: Units on a scale]
Mean ± Standard Deviation
     
Wk2     4.53  ± 1.41     3.5  ± 1.63     3.97  ± 1.26  
Wk6     2.81  ± 1.87     2.59  ± 1.66     2.59  ± 1.58  
Wk10     2.69  ± 1.91     2.63  ± 1.64     2.66  ± 1.77  
Wk18     3.00  ± 1.83     2.94  ± 1.70     2.50  ± 1.67  


Statistical Analysis 1 for Incomplete of Evacuation
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Sensation of Bloating   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]

10.  Secondary:   Sensation of Abdominal Pain/Cramping   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]

11.  Secondary:   Passing of Gas   [ Time Frame: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) ]

12.  Secondary:   Blood Urea Level   [ Time Frame: Pre-treatment(Wk2) & Post-treatment(Wk10) ]

13.  Secondary:   Blood Creatinine Level   [ Time Frame: Pre-treatment(Wk2) & Post-treatment(Wk10) ]

14.  Secondary:   Serum Glutamic Pyruvic Transaminase(SGPT) Level   [ Time Frame: Pre-treatment(Wk2) & Post-treatment(Wk10) ]

15.  Secondary:   Serum Glutamic Oxaloacetic Transaminase(SGOT) Level   [ Time Frame: Pre-treatment(Wk2) & Post-treatment(Wk10) ]

16.  Secondary:   Adverse Effects (e.g. Renal and Liver Function Tests)   [ Time Frame: pre-treatment & post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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