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

NCT00130741 | Completed Phase 1

• 1 other identifier: 391-14.1.05-HMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases, Functional

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

Interventions

CHT - herbal therapy DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Colonic Diseases, Functional

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Y Shapira, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 16, 2005
• Study Start: July 1, 2005
• Study Completion: January 1, 2007
• Last Updated: April 11, 2007

Record last verified: 2007-04

Locations

IL (1)