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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

Background:

IBS (Irritable Bowel Syndrome) is a disorder of motility of the entire GI tract that produces cramping, abdominal pain, constipation, and/or diarrhea and sometimes passing of mucus in bowel movements. In most people with IBS, the GI tract is highly sensitive to many stimuli, including diet and distension from gas. Among dietary suspects are high-fat or other high-calorie meals, dairy products, wheat, citrus fruits, coffee, and tea which can trigger spasms of the colon muscle. During an episode, GI tract contractions become stronger and more frequent, and the resulting rapid motility may lead to diarrhea. When colon motility is reduced, bowel movements do not occur regularly, resulting in constipation. Cramping appears to be induced by strong contractions and increased sensitivity of pain receptors in the large intestine. IBS can be triggered or intensified by stress due to communications between the central nervous system and the nervous system of the small and large intestines. This is sometimes referred to as a brain-gut connection and is supported by inspection of electroencephalogram (EEG) traces which showed significantly greater EEG abnormality in IBS patients (29.2%) than in controls (4.2%) [p<0.02]. The degree of abnormality was positively correlated with colonic motility only in IBS patients (p<0.05) allowing the authors to conclude that there is an electrophysiologic brain-gut interaction in IBS.

IBS can cause great physical discomfort and embarrassment to many of its sufferers, but is not life threatening.

There is no current consensus as to an organic cause of this syndrome and there generally appears to be no sign of disease upon physical examination except for tenderness over the large intestine. The diagnosis is symptom-based, usually throug
Sponsor: Hadassah Medical Organization

Current Primary Outcome: 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

Original Primary Outcome: · To evaluate whether CHT administered 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.

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • a. 30% change on the IBS-36 from baseline to 4 weeks (“no” or “yes”).
  • b. Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of “washout).
  • c. Change in IBS symptoms severity score from baseline to 4 weeks.
  • d. Change in IBS symptoms severity score from 4 to 8 weeks.


Information By: Hadassah Medical Organization

Dates:
Date Received: August 15, 2005
Date Started: July 2005
Date Completion:
Last Updated: April 10, 2007
Last Verified: April 2007