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The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153751
First received: September 8, 2005
Last updated: May 9, 2008
Last verified: May 2008
History of Changes
  Purpose

To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.


Condition Intervention Phase
Colonic Diseases, Functional
 Drug: Traditional Chinese Medicine
Drug: Holopon
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The global assessment of IBS symptom by patients. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual IBS symptoms and QOL assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Traditional Chinese Medicine
They are Common peony root, other herbs.
 Drug: Traditional Chinese Medicine
They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
Other Name: TCM
Active Comparator: Holopon
Holopon
 Drug: Holopon
holopon
Other Name: Western Medicine
Placebo Comparator: placebo
Placebo
 Other: placebo
placebo
Other Name: dummy

Detailed Description:

Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. Epidemiological studies showed that 14% of males and 27% of females in the US (white) have symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition among Chinese (13% in males and 21% in females). IBS is one of the most common conditions leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory. Numerous medications have been proposed for IBS; however, none is convincingly effective. A review and critique of published drug trials for IBS from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all IBS patients. With the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for IBS. Traditional Chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. However, there is a lack of convincing clinical data demonstrating the effectiveness of Chinese medicine in this condition. In this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type IBS. Patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM), 2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week period of randomized double-blind treatment with either HW, WM or placebo and followed by an 8-week of observation period. The IBS symptom and quality of life will be compared.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study.
  • IBS is diagnosed by Rome II criteria [Thompson et al. Gut 2000]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool
  • Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years
  • Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period
  • Informed written consent for participation into study.
  • Ethical approval will be obtained from the Clinical Research Ethics Committee of the University
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153751

Locations
China
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
Hong Kong (SAR), China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Joseph JY Sung, MD CUHK
  More Information

No publications provided

Responsible Party: Dr WK Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00153751     History of Changes
Other Study ID Numbers: JC_IBS
Study First Received: September 8, 2005
Last Updated: May 9, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Traditional Chinese Medicine

Additional relevant MeSH terms:
Colonic Diseases
Colonic Diseases, Functional
Irritable Bowel Syndrome
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013