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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00130741
First received: August 15, 2005
Last updated: April 10, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Colonic Diseases, Functional
Drug: CHT - herbal therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: July 2005
Study Completion Date: January 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130741

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130741     History of Changes
Other Study ID Numbers: 391-14.1.05-HMO-CTIL
Study First Received: August 15, 2005
Last Updated: April 10, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on April 16, 2014