Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 and safe dosage of the formulation in treating IBS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Chinese University of Hong Kong; National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• 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:

1. Improvement with defecation

2. Onset associated with change in frequency of stool

3. 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 Criteria:

• 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).