Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)
Colonic Diseases, Functional
About this trial
This is an interventional treatment trial for Colonic Diseases, Functional
Eligibility Criteria
Inclusion Criteria: Men or women aged 18-70 Diagnosis of irritable bowel syndrome based on the following criteria (ROME II): At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain (at least once per week) with at least 2 of the following features: Relief with defecation; Onset associated with a change in stool frequency; Onset associated with a change in stool consistency. At least two of the following on at least 25% of occasions or days in the last 3 months: Fewer than three bowel movements a week; More than three bowel movements a day; Hard or lumpy stools; Loose (mushy) or watery stools; Straining during a bowel movement; Urgency; Feeling of incomplete bowel movement; Passing mucus during a bowel movement; Abdominal fullness, bloating or swelling. Women of childbearing potential must be using an acceptable method of contraception. Exclusion Criteria: History of severe or intractable IBS, defined as continuous, unremitting and severe abdominal pain greater than 12 hours/day Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study History of laxative abuse Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable) History of metabolic or inflammatory disease that may affect bowel motility, eg., inflammatory bowel disease, diabetes mellitus, sarcoidosis Use of the following concomitant medications: medications that can affect gastrointestinal (GI) motility; other investigational drug use (30 day "washout" required); medications affecting visceral perception; antidepressants; selective serotonin reuptake inhibitors; opioids; narcotic analgesics; antispasmodic and anticonvulsant agents; insulin or other hypoglycemic therapy; thyroid hormones; central nervous system (CNS) depressants. Other significant illness as determined by Investigator Pregnancy History of drug or alcohol abuse within 2 years Insufficient knowledge of English or Hebrew to complete self-assessments to participate in study Any other reason for which Investigator feels that subject's compliance is at question or safety may be compromised.
Sites / Locations
- Hadassah Medical Organization