Health Condition 1: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Device: Use of WinHealth.Care (heal O gut Application): Experimental (TAU plus WinHealth.Care [heal O gut app]) Subjects who are in the Experimental Group will receive 12 weeks of stand
Sponsors
Mr. Shashank Mishra
SMO Clinical Research I Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IBS symptoms based on any change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500 through WinHealth.Care (heal O gut application).Timepoint: Change in IBS symptoms based on any change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500 | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the impact of the DTx platform on the overall quality of life (QoL) of IBS IBS-SSS,DASS21 & EQ-5D-5L in patients. 2. To clinically validate the effectiveness of WinHealth’s DTX application in improving the adherence to medications 3. To determine the rate of adherence to the DTx platform among the study participants.Timepoint: Day 0- Screening & Recruitment-Screening questionnaire,IBS-36 QoL,IBSSSS, DASS21,EQ-5D-5L,Activity questionnaire – Completed by Subject during screening visit. Week 2,4,6,8,10 & 12-IBS-36 QoL form & IBS-SSS Questionnaire Week 4,8 & 12-DASS21 & EQ-5D-5L Activity Questionnaire- thrice in a week, total of 36 times in 12 weeks. | — |
Countries
India
Contacts
Public ContactMr Shashank Mishra
Microheal Wellness Pvt Ltd
Outcome results
None listed