CTRI/2023/11/059987
Recruiting
未知
A Prospective Study to Analyze the Short-Term and Long-Term Effectiveness of WinHealths DTx Platform in Managing and Improving Symptoms of Irritable Bowel Syndrome (IBS). - IBS
Mr. Shashank Mishra0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr. Shashank Mishra
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female participants aged between 18 and 65 years.
- •2\. Clinically diagnosed with Irritable Bowel Syndrome (IBS) as determined by Rome III or IV Criteria. No restrictions on type of IBS.
- •3\. Willing and able to provide informed consent to participate in the study.
- •4\. Willing to complete the study
- •5\. Agreement to input information about their abdominal pain and bowel movements on a daily basis into WinHealth app
- •6\. Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study, and to have the data used for research purposes.
- •7\. Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician. Changes in treatment will be captured using a concomitant medication assessment.
- •8\. Consistent submission of Pain Severity scores via the WinHealth app (data submitted on 80% or more of days in the symptom tracking window)
- •9\. Access to an Android smart phone or other compatible device to access the DTx platform.
Exclusion Criteria
- •1\. Active major psychiatric illness which would potentially interfere with participation in the study
- •2\. Participants with Active eating disorder
- •3\. BMI of 40 or higher
- •4\. Participants with severe comorbidities that may significantly affect the study results.
- •5\. Individuals with a history of major abdominal surgeries (intestinal, reflection and bariatric), and cancer patients under treatment.
- •6\. Pregnant or breastfeeding individuals.
- •7\. Enrolment in active clinical trial/ experimental therapy within the last 30 days
Outcomes
Primary Outcomes
Not specified
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