NCT02364830

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-02-18
• Last updated: 2015-02-18

Locations

2 sites across 1 country: Iran