Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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) versus placebo and short and long-term efficacy in terms of improved IBS, overall quality of life (QOL) and symptomatology.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization

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.