Health Condition 1: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr. Reddyâ??s Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients from eighteen years of age to fifty years of age of either gender 2. Diagnosed with IBS (Using ROME III, ROME IV or Maningâ??s Criteria based on the treating physician discretion) 3. Ongoing medical treatment as per standard of care (SoC) under supervision of Gastroenterologist 4. Comfortable for using smartphone for management and agreeing to follow study related procedures 5. Subscribed to program -based management (Daily BloomTM IBS) pertaining to dietary, psychological and physical interventions 6. Provides written informed consent for participation in the study
Exclusion criteria
Exclusion criteria: 1. Patients with co-existing medically significant conditions affecting the participation as mentioned below: Patients with IBS who have alarm signs (haematochezia, melena, unintentional weight loss, older age of onset of symptoms, family history of IBD, colon cancer, or other significant GI disease. [IBS ACG Guideline]). 2. Patients with untreated/uncontrolled coexisting diseases (e.g. intestinal parasites, malignancy, psychiatric disorders, diabetes mellitus cardiovascular, pulmonary, hepatic, or renal disorder). 3. Patients with (irritable bowel syndrome on inflammatory bowel disease) IBD-IBS 4. In the opinion of the treating physician any other condition that may interfere the study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness 1. To evaluate the change from the baseline in IBS-SSS score at each of the study specific time points 2. To evaluate the change from the baseline in IBS specific QoL score at each of the study specific time points 3. Hospital Anxiety and Depression Scale from baseline to week 14 Safety 1. Safety Monitoring Average number of flare-ups of the IBS symptoms during the study periodTimepoint: Baseline, Week 5, 11 & 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness Adherence will be based on the following 1.Nutritionists: No. of calls vs planned Duration of calls vs planned Food logging or planned 2.Psychological No of calls vs planned Duration of calls or planned Thought worksheets filled or number of flare ups reported 3.Videos No of videos watched or planned Total number of mins viewed or plannedTimepoint: Baseline, Week 5, 11 & 14 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Dr. Reddyâ??s Laboratories Limited
Outcome results
None listed