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CTRI Number  CTRI/2024/07/070859 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Software as Medical Device]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the MyTatva App in Non Alcoholic Fatty Liver Disease Management 
Scientific Title of Study   A Prospective, Randomized Controlled Trial to Assess the Impact of MyTatva Application in Management of Nonalcoholic Fatty Liver Disease 
Trial Acronym  RESET 
Secondary IDs if Any  
Secondary ID  Identifier 
T2300101, Version 02, Date: 10/01/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand V Kulkarni 
Designation  Senior Consultant Hepatology and Liver Transplantation 
Affiliation  AIG Hospitals 
Address  AIG Hospitals 1 Mind Space Road Gachibowli Hyderabad India

Hyderabad
TELANGANA
500032
India 
Phone  8553322434  
Fax    
Email  anandvk90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krunal Chaudhari 
Designation  Senior Associate Medical Monitor 
Affiliation  Digicare Health Solutions Private Limited 
Address  8th Floor N.G. Tower Iscon Cross Roads Satellite Ahmedabad Gujarat

Ahmadabad
GUJARAT
380015
India 
Phone  7447884028  
Fax    
Email  krunal.chaudhari@tatvacare.in  
 
Details of Contact Person
Public Query  
Name  Dr Anand V Kulkarni  
Designation  Senior Consultant Hepatology and Liver Transplantation 
Affiliation  AIG Hospitals 
Address  AIG Hospitals 1 Mind Space Road Gachibowli Hyderabad India

Hyderabad
TELANGANA
500032
India 
Phone  8553322434  
Fax    
Email  anandvk90@gmail.com  
 
Source of Monetary or Material Support  
Digicare Health Solutions Private Limited, 8th Floor, Astron Tower, Iscon Cross Road, Satellite Ahmedabad – 380 015, Gujarat, India  
 
Primary Sponsor  
Name  Digicare Health Solutions Private Limited 
Address  8th Floor, Astron Tower, Iscon Cross Road, Satellite Ahmedabad – 380 015, Gujarat, India 
Type of Sponsor  Other [Digital Health Tech Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manas Panigrahi  All India Institute of Medical Sciences, Bhubaneswar  Department of Gastroenterology, AIIMS Bhubaneswar Sijua Patrapada Dumduma
Khordha
ORISSA 		 9438884267

medgast_manas@aiimsbhubaneswar.edu.in 
Dr Sandeep Satsangi  Apollo Hospitals  Department of Hepatology and Liver transplantation, Apollo Hospitals Bannerghatta Road 154/11, Opposite IIM Bannerghatta Road Bangalore 560076
Bangalore
KARNATAKA 		 7899243962

sandeephepatology@gmail.com 
Dr Anand V Kulkarni  Asian Institute of Gastroenterology Hospitals  Centre of Hepatology, 1 Mindspace Road, Gachibowli, Hyderabad, India 500032
Hyderabad
TELANGANA 		 8553322434

anandvk90@gmail.com 
Dr Abraham Koshy  Lakeshore Hospital and Research Centre Limited  Department of Medical Gastroenterology, XVI/6 l2 Maradu, Nettoor P O Kochi 682040 Kerala
Ernakulam
KERALA 		 9495093420

koshyabe@yahoo.com 
Dr Karan Kumar   Mahatma Gandhi Medical College and Hospital  Department of Surgical Gastroenterology and Liver Transplantation, RIICO Institutional Area Sitapura Tonk Road Jaipur 302 022
Jaipur
RAJASTHAN 		 7835056138

karanbjmc93@gmail.com 
Dr Chetan Kalal   Nanavati Max Super Speciality Hospital  Institute of Gastroenterology, Hepatology and Therapeutic Endoscopy, LIC Colony Suresh Colony Vile Parle West Mumbai
Mumbai
MAHARASHTRA 		 8506873687

dr.chetankalal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee AIIMS Bhubaneswar  Approved 
Institutional Ethics Committee Dr. Balabhai Nanavati Hospital  Approved 
Institutional Ethics Committee Mahatma Gandhi Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee-Clinical studies Apollo Hospital  Approved 
LAKESHORE ETHICS COMMITTEE  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, (2) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MyTatva application with device integration  Patients randomised to the intervention arm will receive the MyTatva mobile app., lifestyle intervention via health coaches, and routine physician advice as per physicians discretion for 24 weeks throughout the trial. 
Comparator Agent  MyTatva application without device integration  Patients randomised to the comparator arm will receive routine advice and standard of care from the PI, throughout the trial period. MyTatva App access will be provided to this group for 24 weeks throughout the trial. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with confirmed diagnosis of NAFLD

Patients with Liver Stiffness Measure (LSM) Values ranges between 7 to 12 kPa measured via FibroScan

Patients with access to a smartphone with internet access/data plan

Patients or caregivers who understands and speaks English sufficiently to be able to use the MyTatva Patient application

Patient is willing to comply with all study procedures and available for the duration of study 
 
ExclusionCriteria 
Details  Patients who have active or recent participation in lifestyle intervention program including a weight loss program less than 90 days before enrolment

Patients who are on active weight loss supplement use

Patients with LSM values above 12 kPa measured via FibroScan

Patients who are unable or not willing to provide informed consent

Patients with other chronic liver diseases

Patients who have secondary causes of hepatic steatosis,
including significant alcohol consumption for men more than 30gram per day and women more than 20gram day

Patients who have severe medical comorbidities or psychiatric illness can be excluded at the discretion of the study PI

Concurrent enrollment in any other interventional clinical trial at the start of study

Enrollment in any other interventional clinical trial 3 months prior to the start of study

Presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with 7 percentage and above body weight in kgs reduction from baseline to the end of 12 weeks and 24 weeks

Change in waist circumference in cm from baseline to the end of 12 weeks and 24 weeks

Change in CAP score in deciBels per meter from baseline to the end of 12 weeks and 24 weeks 		 12 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Waist-Hip Ratio in cm from baseline to the end of 12 weeks and 24 weeks

Change in LSM via FibroScan from baseline to the end of 12 weeks and 24 weeks

Change in HOMA IR from baseline to the end of 12 weeks and 24 weeks

Change in FIB 4 and FAST scores from baseline to the end of 12 weeks and 24 weeks

Change in Patient Related Outcome via Chronic Liver Disease Questionnaire from baseline to the end of 12 weeks and 24 weeks

Change in the body fat percentage from baseline to the end of 12 weeks and 24 weeks

Change in muscle mass from baseline to the end of 12 weeks and 24 weeks

Change in physical activity measured in step counts per day from baseline to the end of 12 weeks and 24 weeks

Percentage of patients with 80 percentage adherence to diet and exercise recommendations at the end of 12 weeks and 24 weeks
 		 12 weeks and 24 weeks 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

MyTatva App, a mobile application (Android version 1.9.7 or higher and iOS version 1.6.8 or higher), is developed by Digital Healthcare Solution Private Limited. Intention for developing  MyTatva App is to track, monitor, and keep records of every single parameter that contributes to overall well-being in adults with NAFLD.

MyTatva App takes control of body condition in the smart way and provides an entire disease management ecosystem right at the fingertips.

With personalized diet, behavioral modification and exercise plans, individual can work on improving their health and track their daily activities by connecting to smart devices. The patient can connect with other patients and stay informed about the latest advances with engaging and scientifically verified educational content.

Therefore, this study has been planned to understand the  impact of lifestyle modification in diet and exercise delivered by MyTatva application in the management of NAFLD.

 
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