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

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.

Full Title of Study: “Randomised Clinical Trial: Enteric-coated Anise-oil Capsules vs. Placebo & Active Controlled in Irritable Bowel Syndrome – A 4 Week Double-blind Study With 2 Weeks Follow-up”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2015

Detailed 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.

Interventions

  • Drug: Anise-oil EC Capsule
    • Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks
  • Other: Placebo
    • One Placebo Capsule/Day for 4 Weeks
  • Drug: Colpermin®
    • Colpermin® Capsule/Day for 4 Weeks

Arms, Groups and Cohorts

  • Active Comparator: Anise-oil EC
    • Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Patients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
  • Placebo Comparator: Placebo
    • Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
  • Active Comparator: Colpermin®
    • Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
    • Time Frame: Baseline
    • (IBS-QOL) questionnaire and 10-point visual scale ranging

Secondary Measures

  • Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
    • Time Frame: 4 weeks after start treatment
    • (IBS-QOL) questionnaire and 10-point visual scale ranging
  • Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
    • Time Frame: End of Follow Up(6 weeks after staring intervention)
    • (IBS-QOL) questionnaire and 10-point visual scale ranging

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Maryam Mosaffa-Jahromi, PharmD., PhDc of Traditional Pharmacy – Shiraz University of Medical Sciences
  • Overall Official(s)
    • Maryam Mosaffa-Jahromi, PhDc, Principal Investigator, Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

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