To Analyze the immediate and long-term effectiveness of WinHealth’s DTx platform to prevent and improve symptoms of irritable bowel syndrome (IBS)

Not Applicable

• Conditions: Health Condition 1: K582- Mixed irritable bowel syndrome

• Registration Number: CTRI/2023/11/059987
• Lead Sponsor: Mr. Shashank Mishra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified