A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation

Functional Constipation Clinical Trial

Official title:

Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695850
• Other study ID #: HHSRF09101501
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: May 2020
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Digestive System Diseases
• Functional Constipation
• Gastrointestinal Diseases
• Gastrointestinal Disorders

Intervention

Drug:
• MZRW
Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.
• Senna
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
• placebo
The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.

Locations

Country	Name	City	State
China	School of Chinese Medicine, Hong Kong Baptist University	Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the responder rate for CSBM during the treatment period	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	8 weeks
Secondary	the responder rate for CSBM during the follow-up period	Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders	8 weeks
Secondary	Individual assessment of constipation and related symptoms	severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe	18 weeks
Secondary	the changes of colonic transit time	It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period.	18 weeks
Secondary	Global symptom assessment	Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.	18 weeks
Secondary	Success of blinding	the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken	18 weeks
Secondary	safety profiles	Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.	18 weeks