NCT02364830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

February 5, 2015

Last Update Submit

February 10, 2015

Conditions

Irritable Bowel Syndrome

Keywords

Pimpinella anisum L.Peppermint oilIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment

    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

    End of Follow Up(6 weeks after staring intervention)

Study Arms (3)

Anise-oil EC

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Colpermin®

ACTIVE COMPARATOR

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

Drug: Colpermin®

Interventions

Anise-oil EC CapsuleDRUG

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

Also known as: Group A
Anise-oil EC
PlaceboOTHER

One Placebo Capsule/Day for 4 Weeks

Also known as: Group B
Placebo
Colpermin®DRUG

Colpermin® Capsule/Day for 4 Weeks

Also known as: Group C
Colpermin®

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Kamran Bagheri Lankarani

Shiraz, Fars, Iran

Location

Dr. Maryam Mosaffa-Jahromi

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Maryam Mosaffa-Jahromi, PhDc

    Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD., PhDc of Traditional Pharmacy

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 18, 2015

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

IR(2)