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

Irritable Bowel Syndrome Clinical Trial

— IBS-Anise  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364830
• Other study ID #: E.C. Anise-oil on IBS
• Secondary ID: Dr.Mosaffa
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2015
• Last updated: February 10, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of HealthIran: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Other:
• Placebo
One Placebo Capsule/Day for 4 Weeks

Drug:
• Colpermin®
Colpermin® Capsule/Day for 4 Weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dr. Kamran Bagheri Lankarani	Shiraz	Fars
Iran, Islamic Republic of	Dr. Maryam Mosaffa-Jahromi	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness	(IBS-QOL) questionnaire and 10-point visual scale ranging	Baseline	Yes
Secondary	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	Yes
Secondary	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)	Yes