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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02364830

Acronym

IBS-Anise

Enrollment

120

Registered

2015-02-18

Start date

2013-04-30

Completion date

2015-01-31

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome

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.

Interventions

DRUGAnise-oil EC Capsule

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

OTHERPlacebo

One Placebo Capsule/Day for 4 Weeks

DRUGColpermin®

Colpermin® Capsule/Day for 4 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	(IBS-QOL) questionnaire and 10-point visual scale ranging

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026