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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Placebo; Drug: Anise-oil EC Capsule; Drug: Colpermin®

• Registration Number: NCT02364830
• Lead Sponsor: Shiraz University of Medical Sciences

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 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-10
• Last Update Submitted: 2015-02-10
• Study First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
Anise-oil EC	Anise-oil EC Capsule	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.
Colpermin®	Colpermin®	Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dr. Kamran Bagheri Lankarani; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of

Dr. Maryam Mosaffa-Jahromi; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of