A clinical study to study the social awareness and Clinical Profiles of Patients With Irritable Bowel Syndrome (Gastric Disease) in India
- Conditions
- Health Condition 1: K589- Irritable bowel syndrome without diarrhea
- Registration Number
- CTRI/2019/07/020067
- Lead Sponsor
- Abbott Healthcare India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female patients aged >= 18 years
2. Patients diagnosed with IBS in last 1 month as per the Asian criteria
3. Patients who are willing to participate in the study and competent to sign a patient authorization form (PAF) for participation in the registry
1. IBS patients with evidence of structural abnormality in the GI tract or diseases/conditions that may affect bowel transit
2. IBS patients with evidence of acute GI conditions like obstructions, bleeding, and perforation, or GI surgery
3. IBS patients with evidence of severe systemic disorders (cardiac, hepatic, neurological, or renal)
4. Pregnant or lactating patients
5. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sociodemographic profile of patients with IBS: Number and percentage of patients with following characteristicsTimepoint: Sociodemographic profile of patients with IBS: Number and percentage of patients with following characteristics
- Secondary Outcome Measures
Name Time Method 1.Symptom burden <br/ ><br>2.Diagnostic and management practices for IBS <br/ ><br>3.Impact of IBS on QoLTimepoint: 1.Mean Gastrointestinal Symptom Rating Scale- Irritable Bowel Syndrome (GSRS-IBS) score <br/ ><br>2.Number and percentage of patients advised additional investigations like colonoscopy, fecal calprotectin, blood count, stool test, etc <br/ ><br>3.Mean score of IBS-36 QoL scale