Status:
COMPLETED
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Chinese University of Hong Kong
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious an...
Detailed Description
The Specific aims of the project are: 1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been di...
Eligibility Criteria
Inclusion
- Age 18- 75
- All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.
- IBS diagnosed by Rome III criteria:
- Recurrent abdominal pain or discomfort at least three days per month in the previous three months
- Symptoms onset at least six months prior to diagnose
- Pain or discomfort associated with two or more of the following:
- Improvement with defecation
- Onset associated with 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 screening and during the two- week run- in period to baseline
- 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 disease (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 use
- Current psychiatric illness or dementia
- Fever or severe illness at baseline (week 0).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03300804
Start Date
May 1 2008
End Date
June 1 2011
Last Update
March 14 2022
Active Locations (1)
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1
Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong
Shatin, Hong Kong