The Effect of Ajwain fruit extract on Improvement of Irritable Bowel Syndrome (IBS) Symptoms
Phase 2
Recruiting
- Conditions
- Irritable Bowel Syndrome (IBS).Irritable bowel syndrome
- Registration Number
- IRCT20160306026938N8
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Adherence to diagnostic criteria of Irritable Bowel Syndrome (IBS) including recurrent abdominal pain at least three days in a month during past three months and beginning of symptoms at least from six months ago plus at least two conditions of three pain alleviation conditions after defecation, variations in number of defecation times and changes in stool consistency
Age range of 18-70 years old
Signing the informed consent
Exclusion Criteria
Being afflicted with any underlying disease
pregnancy
Being allergic to Apiaceae family plants
Bowel dysfunctions including abnormal colonoscopy observations
Lactation period
Consumption of medications for improvement of irritable bowel syndrome symptoms
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal pain. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Diarrhea. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Constipation. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).;Bloating. Timepoint: After intervention (one month after intervention). Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement).
- Secondary Outcome Measures
Name Time Method Quality of life score. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after study being initiated, 2 weeks after termination of the intervention. Method of measurement: Completing 34-item questionnaire of life quality among IBS patients (IBS_QOL34) by the patient himself.