| 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
|
|
|
Primary Sponsor
|
| Name |
IIT Bombay |
| Address |
Main Gate Rd, IIT Area, Powai, Mumbai, Maharashtra 400076 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |