A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation

Constipation Clinical Trial

Official title:

A Randomized Controlled Trial of Chinese Herbal Medicine in Three-dose Regimen for the Treatment of Functional Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299975
• Other study ID #: PID-001
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2006
• Last updated: April 8, 2015
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2015
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Functional constipation (FC) is a common complaint in clinical practice, with the estimated prevalence 14.3% in Hong Kong, as nearly affecting 1 million Hong Kong People in different extent. It is comparable with western population, which is 15% in North America. By the definition of Rome II criteria, FC comprises a group of functional disorders, which presents as persistent difficult, infrequent or seemingly incomplete defecation.

Constipation is often perceived to be benign, easily treated condition with short-term treatment being relatively straightforward. However, the fact is the management of FC is perplexed as some subjects complain of constipation more than decade. Moreover, chronic constipation can develop into more serious bowel complaints, such as faecal impaction, incontinence and bowel perforations. There is also accumulating evidence shown that constipated subjects have significantly higher anxiety and depression scores and lower quality of life. Therefore, the demand of effective agents to normalize bowel function is extremely large.

Conventional treatment for constipation mainly relies on dietary fibre and laxatives. Although there is no credible evidence that any serious problem is associated with their prolonged use, the treatment of it has been suboptimal. First, a recent systematic review pointed out that there were paucity of trials for many commonly used agents, therefore, their use might not be well validated. Second, many patients with severe constipation do not respond adequately or lose of effectiveness after a short period of time. Third, many patients who intake dietary fibre complain of flatulence, distension, bloating and poor taste. As a result, the compliance is low as about 50%. Fourth, the use of osmotic laxatives, such as polyethylene glycol, become increasingly popular due to fewer side effects and better taste, however, the prices are much more expensive than other medications. Many constipation sufferers seek help from alternative medicine, especially from Chinese herbal medicine. For example, according to a telephone survey in Hong Kong, more than 85% of constipated subjects seek for coping strategies, such as asking for medical consultations, taking prescribed medicine and seeking for alternative therapy, involving Chinese medicine.

Traditional Chinese medicine (TCM) is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions. The CHM used in study is derived from classic text of Chinese medicine (Shang Han Lun, Discussion of Cold-induced Disorders), which can "moisten the intestines, drain heat, promote the movement of qi and unblock the bowel".

It is well known that randomized controlled trial (RCT) is the gold standard to test the efficacy of intervention, thus in this project, we attempt to follow the basic requirements of RCT to testify the efficacy and safety of CHM on FC, as well as to determine the optimal dosage. We believe such study will benefit the advancement of CHM, or even as the foundation of research study in future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• MaZiRenWan (MZRW) Low dose
Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
• MaZiRenWan (MZRW) Median dose
Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
• MaZiRenWan (MZRW) High dose
Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks

Locations

Country	Name	City	State
China	Hong Kong Baptist University Chinese Medicine Clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Week11-18	No
Secondary	Bowel Movement		Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)	No
Secondary	Complete Spontaneous Bowel Movement (CSBM)	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.	Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)	No
Secondary	Global Symptoms Improvement	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.	Week6, 10 & 18	No
Secondary	Severity of Constipation	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Sensation of Straining	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Incomplete of Evacuation	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Sensation of Bloating	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Sensation of Abdominal Pain/Cramping	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Passing of Gas	It was a 7-point ordinal scale from 0=not at all to 6=very severe.	Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)	No
Secondary	Adverse Effects (e.g. Renal and Liver Function Tests)		pre-treatment & post-treatment	Yes
Secondary	Blood Urea Level		Pre-treatment(Week2) & Post-treatment(Week10)	Yes
Secondary	Blood Creatinine Level		Pre-treatment(Week2) & Post-treatment(Week10)	Yes
Secondary	Serum Glutamic Pyruvic Transaminase(SGPT) Level		Pre-treatment(Week2) & Post-treatment(Week10)	Yes
Secondary	Serum Glutamic Oxaloacetic Transaminase(SGOT) Level		Pre-treatment(Week2) & Post-treatment(Week10)	Yes

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