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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Anise-oil EC Capsule

Intervention Type DRUG

Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks

Placebo

Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

One Placebo Capsule/Day for 4 Weeks

Colpermin®

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

Group Type ACTIVE_COMPARATOR

Colpermin®

Intervention Type DRUG

Colpermin® Capsule/Day for 4 Weeks

Interventions

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Anise-oil EC Capsule

Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks

Intervention Type DRUG

Placebo

One Placebo Capsule/Day for 4 Weeks

Intervention Type OTHER

Colpermin®

Colpermin® Capsule/Day for 4 Weeks

Intervention Type DRUG

Other Intervention Names

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Group A Group B Group C

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Dr. Maryam Mosaffa-Jahromi

PharmD., PhDc of Traditional Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maryam Mosaffa-Jahromi, PhDc

Role: PRINCIPAL_INVESTIGATOR

Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran