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

Last updated: February 10, 2015
Sponsor: Shiraz University of Medical Sciences
Overall Status: Completed

Phase

3

Condition

Gastrointestinal Diseases And Disorders

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT02364830
E.C. Anise-oil on IBS
Dr.Mosaffa
  • Ages 20-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meeting the Rome III Modular Questionnaire

  • Patients with 50 years were required to have a colonoscopy performed within theprevious 5 years

  • Patients under the age of 50 years were required to have a sigmoidoscopy performed

Exclusion

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 toIBS)

  • Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn'sdisease)

  • 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

Study Design

Total Participants: 120
Study Start date:
April 01, 2013
Estimated Completion Date:
January 31, 2015

Study Description

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.

Connect with a study center

  • Dr. Kamran Bagheri Lankarani

    Shiraz, Fars
    Iran, Islamic Republic of

    Site Not Available

  • Dr. Maryam Mosaffa-Jahromi

    Shiraz, Fars
    Iran, Islamic Republic of

    Site Not Available

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