Health Condition 1: K581- Irritable bowel syndrome with constipation Health Condition 2: null- Patients with IBS -C
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Symptom duration as per Rome IV criteria Rome IV Criteria for Diagnosing IBS# Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following criteria: 1.Related to defecation 2.Associated with a change in frequency of stool 3.Associated with a change in form (appearance) of stool #Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis IBS-C - hard or lumpy stools at least 25% of the time, and loose or watery stools less than 25% of the time
Exclusion criteria
Exclusion criteria: Patients are excluded if they have one or more of the following conditions: 1. Co-morbid illness : IHD, CKD, cirrhosis of liver, severe respiratory illness, diabetes mellitus, and COPD 2. Predominant diarrhea (IBS-D), a combination of the two (IBS-M, or â??mixedâ??), or undefined (IBS-U) 3. Current use of psychiatric medication or in the previous 6 months, pregnant or lactating women, patients with malignancy, unconfirmed diagnosis 4. Patients denying to follow the lifestyle modification protocol and give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 50% reduction in the predominant or target symptom (abdominal pain/abdominal distension/abnormal bowel habit) along with a similar improvement in subjective wellbeing will be used as clinically useful index of outcome. Stool consistency will be assessed on the basis of patient-reported symptoms with the Bristol Stool Form (BSF). Patients will be asked to use a Visual analogue scale (VAS) scale to rate their worst abdominal pain over the past 24 h on a daily basis (using a diary).Timepoint: 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
AIIMS Delhi