The Effect of Anise-oil capsules on IBS Treatment

Phase 3

• Conditions: on- Response IBS Patients.; Irritable bowel syndrome

• Registration Number: IRCT201205069651N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness. Timepoint: Baseline. Method of measurement: (IBS-QOL) questionnaire and 10-point visual scale ranging.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment. Timepoint: End of Follow Up(6 weeks after staring intervention). Method of measurement: (IBS-QOL) questionnaire and 10-point visual scale ranging.