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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Anise-oil EC Capsule
* Other: Placebo
* Drug: Colpermin®


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anise-oil EC<br>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<br>* Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks<br>* Other names: Group A;|
| Placebo Comparator: Placebo<br>Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. | Other: Placebo<br>* One Placebo Capsule/Day for 4 Weeks<br>* Other names: Group B;|
| Active Comparator: Colpermin®<br>Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. | Drug: Colpermin®<br>* Colpermin® Capsule/Day for 4 Weeks<br>* Other names: Group C;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome