Clinical trial NCT00299975: A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Official title: A Randomized Controlled Trial of Chinese Herbal Medicine in Three-dose Regimen for the Treatment of Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: Randomized Controlled Trials
Medicine, Chinese Traditional
Medicine, Herbal
Constipation
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2006-03-07
Enrollment: 97
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Responder for Complete Spontaneous Bowel Movement (CSBM)
timeFrame: Week3-10
Secondary outcomes:
measure: Responder for Complete Spontaneous Bowel Movement (CSBM)
timeFrame: Week11-18
measure: Bowel Movement
timeFrame: Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)
measure: Complete Spontaneous Bowel Movement (CSBM)
timeFrame: Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)
measure: Global Symptoms Improvement
timeFrame: Week6, 10 & 18
measure: Severity of Constipation
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Sensation of Straining
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Incomplete of Evacuation
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Sensation of Bloating
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Sensation of Abdominal Pain/Cramping
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Passing of Gas
timeFrame: Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)
measure: Adverse Effects (e.g. Renal and Liver Function Tests)
timeFrame: pre-treatment & post-treatment
measure: Blood Urea Level
timeFrame: Pre-treatment(Week2) & Post-treatment(Week10)
measure: Blood Creatinine Level
timeFrame: Pre-treatment(Week2) & Post-treatment(Week10)
measure: Serum Glutamic Pyruvic Transaminase(SGPT) Level
timeFrame: Pre-treatment(Week2) & Post-treatment(Week10)
measure: Serum Glutamic Oxaloacetic Transaminase(SGOT) Level
timeFrame: Pre-treatment(Week2) & Post-treatment(Week10)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Baptist University Chinese Medicine Clinic
Study officials:
affiliation: Hong Kong Baptist University
name: ZhaoXiang Bian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.