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CTRI Number  CTRI/2022/05/042359 [Registered on: 04/05/2022] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A pilot study to evaluate accuracy of a digital platform which validates early risk and severity of Non-alcoholic Fatty Liver Disease (NAFLD) and disease management approach in Indian NAFLD patients 
Scientific Title of Study   Prospective, randomized, two-arm, interventional pilot study to evaluate accuracy of a digital platform that validates early risk and severity of Non-alcoholic Fatty Liver Disease (NAFLD) and disease management approach in Indian NAFLD patients 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Mutreja 
Designation  Homeopathic consultant 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Department of Homeopathy, first floor, OPD room number 2, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  99310421121  
Fax    
Email  kirti.m@bhaktivedantahospital.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kirti Mutreja 
Designation  Homeopathic consultant 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Department of Homeopathy, first floor, OPD room number 2, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  99310421121  
Fax    
Email  kirti.m@bhaktivedantahospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kirti Mutreja 
Designation  Homeopathic consultant 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Department of Homeopathy, first floor, OPD room number 2, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  99310421121  
Fax    
Email  kirti.m@bhaktivedantahospital.com  
 
Source of Monetary or Material Support  
IIT Bombay 
 
Primary Sponsor  
Name  IIT Bombay 
Address  Main Gate Rd, IIT Area, Powai, Mumbai, Maharashtra 400076 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirti Mutreja  Bhaktivedanta Hospital and Research Institute  Department of Homeopathy, first floor, OPD room number 2, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road, Maharashtra 401107
Thane
MAHARASHTRA 
99310421121

kirti.m@bhaktivedantahospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lycopodium, Cardus marianus, Cinchona, Chelidonium, Carbo Veg, Calcarea Carb, Lapis alba, Phos, Acid Phos, Merc, Picric acid,Vanadium Met, Kali Bichromicum, Kali Carb, Lyssin, Bryonia Alba, Nux Vomica   Dose and frequency varies with individual patient as these are homeopathic medications 
Comparator Agent  Standard of care for Non-alcoholic Fatty Liver Disease  The standard of care and the dose and frequency will vary according to the patient and disease profile 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy individuals confirmed to be free from NAFLD by the doctor for the Control Group.
2. Patients with confirmed NAFLD as indicated in the Liver Profile Tests for the NAFLD Group
3. Subjects of age 18 to 60 years.
4. Gender -All
5. Ability to comply with study visits and provide informed consent.
6. Diagnostic data are available for algorithm validation.
7. Ability to understand and the willingness to sign a written informed consent document.
 
 
ExclusionCriteria 
Details  1. Evidence of severe or uncontrolled systemic diseases, active bleeding diathesis, or active infection including hepatitis B, hepatitis C, and HIV. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Benchmark and evaluate accuracy of a digital NAFLD management platform with disease severity prediction in the Indian population.
2. Evaluate the accuracy of the algorithm for early validation of NAFLD.

 
1. 0,3,6 months
2. 0,3,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Benchmark NAFLD disease management algorithm.  0, 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   09/05/2022 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Non-alcoholic fatty liver disease (NAFLD) is a systemic disorder with a complex multifactorial pathogenesis and heterogenous clinical manifestations. NAFLD is the most common cause of chronic liver disease in many countries worldwide. It is already highly prevalent in the general population, and owing to a rising incidence of obesity and diabetes mellitus, the incidence of NAFLD and its impact on global healthcare are expected to increase in the future. A subset of patients with NAFLD develops progressive liver disease leading to cirrhosis, hepatocellular carcinoma, and liver failure. NAFLD has emerged as one of the leading causes of cirrhosis and hepatocellular carcinoma in recent years. Compared with the general population, NAFLD increases the risk of liver-related, cardiovascular and all-cause mortality. NAFLD increases the risk and contributes to aggravation of the pathophysiology of atherosclerosis, cardiovascular diseases, diabetes mellitus, and chronic kidney disease. The increasing global prevalence of NAFLD is mainly attributed to the silent manifestation of the disease, which is often disregarded by the common population. To address the increasing burden of NAFLD, it is necessary to identify early signs of the disease and implement diet and lifestyle modifications and natural treatment modalities to delay or alleviate disease onset. The aim of our study is to validate an algorithm designed for early prediction of NAFLD among healthy Indians. The algorithm also indicates the severity of the disease and indicates a suitable disease management plan accordingly. In addition to that we aim to predict and analyze the parameters which lead to severity of NAFLD, its faster progression to cirrhosis and poorer prognosis. This will help to create a predictive analysis model which can be used to educate and guide the patients by means of graphic visualization of their health condition if corrective steps are not taken. As we know, human beings present with different attitudes and mental dispositions. Some of them promptly switch over to a healthier lifestyle on receiving the diagnosis of NAFLD or any lifestyle disease. But unfortunately, most patients we encounter, show laid back approach towards their health, partly due to lack of motivation and partly because of the paucity of knowledge where their present state of health can land them if they do not take adequate corrective steps. There is nothing better than a visual depiction of their prognosis (if the disease parameters progress at the present rate) to impress upon them the necessity of care to prevent the dreaded prognosis. The data collected by this platform will help to create a base for the predictive analysis model with and without corrective measures and a visual depiction of future prognosis.

 
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