Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)
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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.
A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)
Study Start Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
To evaluate whether CHT administered orally (PO) induces a change in the overall QOL score from baseline values at 4 weeks of treatment measured via the IBS 36 questionnaire in patients with irritable bowel syndrome, relative to placebo
Secondary Outcome Measures :
30% change on the IBS-36 from baseline to 4 weeks ("no" or "yes")
Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of "washout")
Change in IBS symptoms severity score from baseline to 4 weeks
Change in IBS symptoms severity score from 4 to 8 weeks
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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;
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.
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
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.