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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014