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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00130741
• Date of registration: 15/08/2005
• Primary sponsor: Hadassah Medical Organization
• Public title: Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)
• Scientific 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)
• Date of first enrolment: July 2005
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00130741
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Michael Y Shapira, MD
• Affiliation: Hadassah Medical Organization

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colonic Diseases, Functional

Intervention(s)

Drug: CHT - herbal therapy

Primary Outcome(s)

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(s)

30% change on the IBS-36 from baseline to 4 weeks ("no" or "yes")

Change in IBS symptoms severity score from 4 to 8 weeks

Change in IBS symptoms severity score from baseline to 4 weeks

Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of "washout")

Secondary ID(s)

391-14.1.05-HMO-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors