A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
A Randomized Controlled Trial of Chinese Herbal Medicine in Three-dose Regimen for the Treatment of Functional Constipation
1 other identifier
interventional
97
1 country
1
Brief Summary
Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
December 16, 2011
CompletedApril 24, 2015
April 1, 2015
10 months
March 6, 2006
August 2, 2011
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responder for Complete Spontaneous Bowel Movement (CSBM)
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.
Week3-10
Secondary Outcomes (15)
Responder for Complete Spontaneous Bowel Movement (CSBM)
Week11-18
Bowel Movement
Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)
Complete Spontaneous Bowel Movement (CSBM)
Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)
Global Symptoms Improvement
Week6, 10 & 18
Severity of Constipation
Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
- +10 more secondary outcomes
Study Arms (3)
MaZiRenWan (MZRW) Low dose
EXPERIMENTALMaZiRenWan (MZRW) Low dose 2.5g sachet by mouth, twice daily for 8 weeks
MaZiRenWan (MZRW) Median dose
EXPERIMENTALMaZiRenWan (MZRW) Median dose 5.0g sachet by mouth, twice daily for 8 weeks
MaZiRenWan (MZRW) High dose
EXPERIMENTALMaZiRenWan (MZRW) High dose 7.5g sachet by mouth, twice daily for 8 weeks
Interventions
Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of functional constipation with Rome II criteria
- General stool type belongs to Type 1 to 4 according to Bristol Stool Form Scale
- Complete spontaneous bowel movement≦2 movements per week
You may not qualify if:
- Anti-diarrhoeal therapy
- Drug-induced constipation
- Medical history of important bowel pathology, such as inflammatory bowel disease, congenital or acquired megacolon / megarectum
- Medical history of previous abdominal surgery
- Taking chronic medications that contain any kind of herbs, mineral, or specific vitamin supplements
- Medical history of carbohydrate malabsorption, hormonal disorder, cancer, diabetes mellitus, hypothyroidism, asthma, renal impairment and/or any other serious diseases
- History of laxative abuse
- History of allergy to Chinese herbal medicine
- Psychiatric or addictive disorders
- Pregnancy or breast-feeding
- Any other serious diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong Kong Baptist University Chinese Medicine Clinic
Hong Kong, China
Related Publications (1)
Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2.
PMID: 21045817RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Zhao-xiang Bian
- Organization
- Hong Kong Baptist University
Study Officials
- PRINCIPAL INVESTIGATOR
ZhaoXiang Bian, PhD
Hong Kong Baptist University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Clinical Division
Study Record Dates
First Submitted
March 6, 2006
First Posted
March 7, 2006
Study Start
October 1, 2006
Primary Completion
August 1, 2007
Study Completion
October 1, 2007
Last Updated
April 24, 2015
Results First Posted
December 16, 2011
Record last verified: 2015-04