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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Fol

Brief 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.

Detailed Summary: 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.
Sponsor: Shiraz University of Medical Sciences

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Shiraz University of Medical Sciences

Dates:
Date Received: February 5, 2015
Date Started: April 2013
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015