- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153751
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
May 9, 2008 updated by: Chinese University of Hong Kong
Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS
To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong (SAR), China
- Li Ka Shing Specialist Clinic, Prince of Wales Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
Placebo
|
placebo
Other Names:
|
Experimental: Traditional Chinese Medicine
They are Common peony root, other herbs.
|
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 Names:
|
Active Comparator: Holopon
|
holopon
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The global assessment of IBS symptom by patients.
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Individual IBS symptoms and QOL assessment
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph JY Sung, MD, CUHK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
May 13, 2008
Last Update Submitted That Met QC Criteria
May 9, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JC_IBS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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