Clinical trial NCT01695850: A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Official title: Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Constipation
Gastrointestinal Disorders
Keywords: Randomized controlled trial
Drugs,Chinese Herbal
Constipation/drug therapy
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth Hospital, Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2012-09-28
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.

Detailed description: Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will undergo an 8-week treatment and an 8-week follow-up.

Eligibility criteria: Inclusion Criteria:

* either gender aged 18 to 65 years
* have FC diagnosed as Rome III criterial
* have diagnosis of Excessive Constipation according to the TCM theory
* complete spontaneous bowel movement (CSBM) ≦2times/w
* severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period
* normal colonic evaluation (colonoscopy or barium enema) within 12 months
* normal liver and renal function in blood test within 3 months

Exclusion Criteria:

* drug-induced constipation
* secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
* abdominal surgery (i.e. Caesarean operation)
* severe diseases (i.e. cancer and acute present asthma)
* allergy to CHM (i.e. G6PD deficiency), senna and tartrazine
* pregnancy or breast-feeding
* psychiatric or addictive disorders

Primary outcomes:
measure: the responder rate for CSBM during the treatment period
timeFrame: 8 weeks
Secondary outcomes:
measure: the responder rate for CSBM during the follow-up period
timeFrame: 8 weeks
measure: Individual assessment of constipation and related symptoms
timeFrame: 18 weeks
measure: the changes of colonic transit time
timeFrame: 18 weeks
measure: Global symptom assessment
timeFrame: 18 weeks
measure: Success of blinding
timeFrame: 18 weeks
measure: safety profiles
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Chinese Medicine, Hong Kong Baptist University
state: Hong Kong
Study officials:
affiliation: School of Chinese Medicine, Hong Kong Baptist University
name: Zhao Xiang Bian, MD, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhong LLD, Cheng CW, Kun W, Dai L, Hu DD, Ning ZW, Xiao HT, Lin CY, Zhao L, Huang T, Tian K, Chan KH, Lam TW, Chen XR, Wong CT, Li M, Lu AP, Wu JCY, Bian ZX. Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1303-1310.e18. doi: 10.1016/j.cgh.2018.04.005. Epub 2018 Apr 12.
citation: Zhong LL, Cheng CW, Chan Y, Chan KH, Lam TW, Chen XR, Wong CT, Wu JC, Bian ZX. Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. Trials. 2013 Nov 4;14:366. doi: 10.1186/1745-6215-14-366.