Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- the responder rate for CSBM during the treatment period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MZRW
MZRW is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo).
干预措施: MZRW (Drug)
MZRW
MZRW is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo).
干预措施: placebo (Drug)
Senna
Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
干预措施: Senna (Drug)
Senna
Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
干预措施: placebo (Drug)
Placebo
Placebo MZRW and Placebo Senna
干预措施: placebo (Drug)
结局指标
主要结局
the responder rate for CSBM during the treatment period
时间窗: 8 weeks
a clinically meaningful endpoint by combining an objective measure (number of bowel movement) with a subjective measure (feelings of patients as to completeness of defecation,Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders
次要结局
- the responder rate for CSBM during the follow-up period(8 weeks)
- Individual assessment of constipation and related symptoms(18 weeks)
- the changes of colonic transit time(18 weeks)
- Global symptom assessment(18 weeks)
- Success of blinding(18 weeks)
- safety profiles(18 weeks)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University