A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
This study has been completed.
Sponsor:
Hong Kong Baptist University
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
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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
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 |
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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| 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 |
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| 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
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 |