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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Other: Placebo; Drug: Anise-oil EC Capsule; Drug: Colpermin®

Study type: Interventional

Funder types: Other

Identifiers

NCT02364830

E.C. Anise-oil on IBS

Dr.Mosaffa (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Anise-oil EC

Active Comparator group

Description:

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.

Treatment:

Drug: Anise-oil EC Capsule

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Colpermin®

Active Comparator group

Description:

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

Treatment:

Drug: Colpermin®