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


  Outcome Measures
  Show All Outcome Measures

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) ]

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Prof. Zhao-xiang Bian
Organization: Hong Kong Baptist University
phone: (852) 3411 2905
e-mail: bzxiang@hkbu.edu.hk


Publications of Results:

Responsible Party: ZhaoXiang Bian, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT00299975     History of Changes
Other Study ID Numbers: PID-001
Study First Received: March 6, 2006
Results First Received: August 2, 2011
Last Updated: November 14, 2011
Health Authority: Hong Kong: Ethics Committee