Status:
COMPLETED
Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Colonic Diseases, Functional
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an additional two week baseline observation period to evaluate the safety of combination herbal therapy (CHT) ...
Detailed Description
Background: IBS (Irritable Bowel Syndrome) is a disorder of motility of the entire GI tract that produces cramping, abdominal pain, constipation, and/or diarrhea and sometimes passing of mucus in bow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00130741
Start Date
July 1 2005
End Date
January 1 2007
Last Update
April 11 2007
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120