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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130741
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : April 11, 2007
Information provided by:
Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Colonic Diseases, Functional Drug: CHT - herbal therapy Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 : July 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 30% change on the IBS-36 from baseline to 4 weeks ("no" or "yes")
  2. Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of "washout")
  3. Change in IBS symptoms severity score from baseline to 4 weeks
  4. 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:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130741

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization Identifier: NCT00130741     History of Changes
Other Study ID Numbers: 391-14.1.05-HMO-CTIL
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases