Status:
COMPLETED
The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
University of Maryland
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of quality of life of patients with Irritable Bowel Syndrome.
Detailed Description
Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients s...
Eligibility Criteria
Inclusion
- All IBS patients attending the Gastroenterology Clinic of the Prince of Wales Hospital of Hong Kong.
- Age 18-75 inclusive
- IBS diagnosed by Rome III criteria:
- Recurrent abdominal pain or discomfort at least three days per month in the previous three months
- Symptom onset at least six months prior to diagnosis
- Pain or discomfort associated with two or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
- No "global symptom improvement" as rated by patients (see below) at baseline and during the two-week run-in period
- Normal full blood count, liver function test and renal function test.
- Informed written consent for participation into study.
- Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.
Exclusion
- Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained).
- Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
- Lactose intolerance
- Severe liver diseases (e.g. cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level \> 150mmol/L)
- Women who are pregnant, lactating or not practicing proper contraception
- Known hypersensitivity to herbal medicine
- Concommitant use of prescription antidepressant medication.
- Current alcoholism and drug abuse
- Current psychiatric illness or dementia
- Fever or severe illness at baseline (week 0).
Key Trial Info
Start Date :
May 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00676975
Start Date
May 26 2008
End Date
August 30 2011
Last Update
April 25 2017
Active Locations (1)
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1
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
Hong Kong (sar), China, 852