Clinical trial NCT02364830: Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Pimpinella anisum L.
Peppermint oil
Irritable Bowel Syndrome
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
timeFrame: Baseline
Secondary outcomes:
measure: Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
timeFrame: 4 weeks after start treatment
measure: Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
timeFrame: End of Follow Up(6 weeks after staring intervention)
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Dr. Kamran Bagheri Lankarani
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Dr. Maryam Mosaffa-Jahromi
state: Fars
Study officials:
affiliation: Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
name: Maryam Mosaffa-Jahromi, PhDc
role: PRINCIPAL_INVESTIGATOR
References: