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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anise-oil EC Capsule
Placebo
Colpermin®
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Dr. Kamran Bagheri Lankarani
  • Dr. Maryam Mosaffa-Jahromi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Anise-oil EC

Placebo

Colpermin®

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
(IBS-QOL) questionnaire and 10-point visual scale ranging

Secondary Outcome Measures

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
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

Full Information

First Posted
February 5, 2015
Last Updated
February 10, 2015
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02364830
Brief Title
Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anise-oil EC
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
Arm Title
Colpermin®
Arm Type
Active Comparator
Arm Description
Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
Intervention Type
Drug
Intervention Name(s)
Anise-oil EC Capsule
Other Intervention Name(s)
Group A
Intervention Description
Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Group B
Intervention Description
One Placebo Capsule/Day for 4 Weeks
Intervention Type
Drug
Intervention Name(s)
Colpermin®
Other Intervention Name(s)
Group C
Intervention Description
Colpermin® Capsule/Day for 4 Weeks
Primary Outcome Measure Information:
Title
Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
Description
(IBS-QOL) questionnaire and 10-point visual scale ranging
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
Description
(IBS-QOL) questionnaire and 10-point visual scale ranging
Time Frame
4 weeks after start treatment
Title
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
Description
(IBS-QOL) questionnaire and 10-point visual scale ranging
Time Frame
End of Follow Up(6 weeks after staring intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Mosaffa-Jahromi, PhDc
Organizational Affiliation
Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Kamran Bagheri Lankarani
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Facility Name
Dr. Maryam Mosaffa-Jahromi
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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