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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Anise-oil EC Capsule; Other: Placebo; Drug: Colpermin®

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Dr. Kamran Bagheri Lankarani
    • Shiraz, Fars, Iran, Islamic Republic of
      • Dr. Maryam Mosaffa-Jahromi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Anise-oil EC Capsule; Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks; Other Names: Group A
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.	Other: Placebo; One Placebo Capsule/Day for 4 Weeks; Other Names: Group B
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.	Drug: Colpermin®; Colpermin® Capsule/Day for 4 Weeks; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Maryam Mosaffa-Jahromi, PhDc, Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Peppermint oil; Pimpinella anisum L.
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: E.C. Anise-oil on IBS; Dr.Mosaffa (Registry Identifier: Dr.Mosaffa)