| CTRI Number |
CTRI/2023/11/059987 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Digital Therapeutics ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Analyze the immediate and long-term effectiveness of WinHealth’s DTx platform to prevent and improve symptoms of irritable bowel syndrome (IBS) |
|
Scientific Title of Study
|
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). |
| Trial Acronym |
IBS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHW/WHC/2023-01, Version 1.0 Dated 16 Oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rami Reddy Yalaka |
| Designation |
Senior Consultant Gastroenterology |
| Affiliation |
Star Hospitals |
| Address |
Star Hospitals
Survey No. 74, Financial District, Nanakramaguda, Makthakousarali, Telangana - 500008
Hyderabad
TELANGANA
500008
India |
| Phone |
9815192032 |
| Fax |
|
| Email |
yrrpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Shashank Mishra |
| Designation |
CEO |
| Affiliation |
Microheal Wellness Pvt Ltd |
| Address |
Microheal Wellness Pvt Ltd
SILVER SPRING BUNGLOWS, 21 LIVING BUNGALOW NO.18 DIVINE ROAD, SCIENCE CITY, AHMEDABAD(GJ)
Ahmadabad
GUJARAT
380060
India |
| Phone |
7376113646 |
| Fax |
|
| Email |
shashank12winger@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shashank Mishra |
| Designation |
CEO |
| Affiliation |
Microheal Wellness Pvt Ltd |
| Address |
Microheal Wellness Pvt Ltd
SILVER SPRING BUNGLOWS, 21 LIVING BUNGALOW NO.18 DIVINE ROAD, SCIENCE CITY, AHMEDABAD(GJ)
GUJARAT
380060
India |
| Phone |
7376113646 |
| Fax |
|
| Email |
shashank12winger@gmail.com |
|
|
Source of Monetary or Material Support
|
| MicroHeal Wellness Pvt. Ltd
SILVER SPRING BUNGLOWS, 21 LIVING BUNGALOW NO.18 DIVINE ROAD, SCIENCE CITY AHMEDABAD Ahmedabad GJ 380060 |
|
|
Primary Sponsor
|
| Name |
Mr. Shashank Mishra |
| Address |
SILVER SPRING BUNGLOWS, 21 LIVING BUNGALOW NO.18 DIVINE ROAD, SCIENCE CITY, AHMEDABAD(GJ)- 380060 |
| Type of Sponsor |
Other [Digital Therapeutics Application] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SMO Clinical Research I Pvt Ltd |
261, 15th Main, RMV Extension, Sadashivanagara, Bangalore - 560080 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rami Reddy Yalaka |
Star Hospitals |
Star Hospitals
Department of Gastroenterology
1st floor, 4th OPD, No. 74, Financial District, Nanakramaguda,Makthakousarali, Telangana - 500008
Hyderabad
TELANGANA |
9815192032
yrrpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Star Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 standard program from the WinHealth app in addition to their treatment as usual (TAU). |
| Comparator Agent |
Usual Treatment |
No Intervention: Control Group (TAU only)
Treatment as Usual (TAU) for IBS patients are tailored to each individuals needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
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 Outcome
|
| Outcome |
TimePoints |
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. |
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. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2023 |
| Date of Study Completion (India) |
05/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a prospective study conducted on a sample population of patients clinically
diagnosed by a physician that the patient suffers from Irritable Bowel Syndrome
(IBS). The participants will be recruited from a gastroenterology
hospital/clinic. The patients, who meet eligibility criteria, will be enrolled
in the study after obtaining their consent.
All
patients will go through the initial assessment where details about their
demographics, symptoms severity, and lifestyle including dietary and exercise
habits, and other relevant medical or surgical history will be taken.
The
sample population will then be divided into two cohorts of patients. To reduce
the risk of bias, both cohorts will have a good representation and equal
distribution of patient demographics (Age, weight, sex, etc.) and their IBS
symptom severity score (IBS-SSS).
Primary
Purpose: Management and Improvisation through WinHealth’s DTx platform in
preventing and improving symptoms of IBS, leading to better patient outcomes
and improved quality of life. |