Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome

Shiraz University of Medical Sciences120 enrolled

Overview

Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating.

The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Irritable Bowel Syndrome

Interventions

Anise-oil EC CapsuleDRUG

Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks

PlaceboOTHER

One Placebo Capsule/Day for 4 Weeks

Colpermin®DRUG

Colpermin® Capsule/Day for 4 Weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Meeting the Rome III Modular Questionnaire * Patients with 50 years were required to have a colonoscopy performed within the previous 5 years * Patients under the age of 50 years were required to have a sigmoidoscopy performed Exclusion Criteria: * Unable or unwilling patients to use an acceptable method of birth control * Pregnant or nursing females * Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS) * Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn's disease) * Mechanical obstruction * Unexplained significant weight loss or rectal bleeding * Diagnosis of any medical condition associated with constipation (other than IBS) * Cancer * Abnormal laboratory tests * Abuse of alcohol or drugs

Locations (2)

Dr. Kamran Bagheri Lankarani

Shiraz, Fars, Iran

Dr. Maryam Mosaffa-Jahromi

Shiraz, Fars, Iran

Outcomes

Primary Outcomes

Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness

(IBS-QOL) questionnaire and 10-point visual scale ranging

Time frame: Baseline

Secondary Outcomes

Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment

(IBS-QOL) questionnaire and 10-point visual scale ranging

Time frame: 4 weeks after start treatment

Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment

(IBS-QOL) questionnaire and 10-point visual scale ranging

Time frame: End of Follow Up(6 weeks after staring intervention)

Data from ClinicalTrials.gov

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