| CTRI Number |
CTRI/2023/10/059025 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effectiveness and safety of Saroglitazaar 4mg in persons with Nonalcoholic fatty liver disease |
|
Scientific Title of Study
|
A Multicentric, Prospective, 0pen-labeled, clinical trial to assess the efficacy and safety of Saroglitazaar Magnesium 4mg along with standard of care (SOC), in the treatment of Metabolic Associated Steatotic Liver Disease (MASLD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCDC/03/2023 Version 1 Date 01-08-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DINESH KUMAR |
| Designation |
DIRECTOR |
| Affiliation |
Harsha Clinic and Diabetes Centre |
| Address |
Harsha Clinic and Diabetes Centre
Medicine Department
155CHA/160B, SINGAR NAGAR ALAMBAGH KANPUR ROAD LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226005
India |
| Phone |
9839007147 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DINESH KUMAR |
| Designation |
DIRECTOR |
| Affiliation |
Harsha Clinic and Diabetes Centre |
| Address |
Medicine Department
Harsha clinic and Diabetes Centre
Ground Floor
155CHA/160B, SINGAR NAGAR ALCentreAMBAGH KANPUR ROAD LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226005
India |
| Phone |
9839007147 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DINESH KUMAR |
| Designation |
DIRECTOR |
| Affiliation |
Harsha Clinic and Diabetes Centre |
| Address |
medicine department
Harsha clinic and diabetes centre 155CHA/160B, SINGAR NAGAR ALAMBAGH KANPUR ROAD LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226005
India |
| Phone |
9839007147 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| DINESH KUMAR
Harsha Clinic and Diabetes
Centre
Udyan Health Care Pvt Ltd
Eldeco 1 , Bangla Bazaar Lucknow |
|
|
Primary Sponsor
|
| Name |
DINESH KUMAR |
| Address |
Harsha Clinic and Diabetes Centre,555CHA/160B, Singar Nagar
Alambagh Lucknow Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar Praful Chandra |
Chandra Diabetes and Heart Clinic |
D-4/658, Vijayant Khand Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH |
7800992222
drkpchandra@gmail.com |
| Dr Dinesh Kumar |
Harsha Clinic and Diabetes Centre |
555Cha/160B, Puran Nagar,Alambagh,Kanpur Road Lucknow 226005
Lucknow
UTTAR PRADESH |
9839007147
dineshharshaclinic@gmail.com |
| Dr Harshita Lachhwani |
Harsha Clinic and Diabetes Centre |
555CHA/160B Puran Nagar,Alambagh Lucknow 226005
Lucknow
UTTAR PRADESH |
8429148309
harshitalachhwani98@gmail.com |
| Dr Rajiv Awasthi |
Prarthana Clinic and Diabetes Care Center |
510,179,3-Saptrishi Appartment,Surajbali Marg,New Hyderabad,Hussanganj
Lucknow
UTTAR PRADESH |
9838281506
rajiv.max@gmail.com |
| Dr Mukulesh Gupta |
Udyan Health Centre Pvt Ltd |
730,Udyan-1,Eldeco,Oppo AWHO,Near Bangla Bazaar,
Lucknow
UTTAR PRADESH |
9336046146
drmukulesh@yahoo.com |
| Dr Tuhina Gupta |
Udyan Health Centre Pvt Ltd |
730, Udyan 1 Eldeco near Bangla Bazaar 226012
Lucknow
UTTAR PRADESH |
05222989996
tuhinaemail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Instituional Human Ethics Committee Udyaan Healthcare |
Approved |
| Instituional Human Ethics Committee Udyaan Healthcare |
Approved |
| Instituional Human Ethics Committee Udyaan Healthcare |
Approved |
| Instituional Human Ethics Committee Udyaan Healthcare |
Approved |
| Instituional Human Ethics Committee Udyaan Healthcare |
Approved |
| Institutional Human Ethics Committee Udyaan Healthcare |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Saroglitazaar Magnesium |
4mg Tablet, Once daily, orally at night before dinner for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age > 18 years
Body Mass Index > 23kg/m2
Having at least 2 of the 5 parameters of Metabolic Syndrome: Hypertension or taking any drugs for hypertension, Diabetes or prediabetes or taking any drugs for diabetes, Obesity, High Triglyceride and low HDL |
|
| ExclusionCriteria |
| Details |
Established diagnosis of Cirrhosis
Persons with T1DM
A person already on Thiazolidinediones, Vitamin E.
Persons taking alcohol in a quantity more than the standard limits set by AASLD (Asia PACIFIC region)
Persons having positive HBsAg or anti-HCV
Persons on steatogenic drugs like amiodarone, methotrexate, oral contraceptives, and steroids.
Persons with other causes of liver disease e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease
Pregnant and Lactating females
Persons having an underlying disease like acute viral hepatitis, congestive hepatomegaly, or biliary congestion can disturb the estimation done by VCTE.
Persons having known allergy to saroglitazaar
Persons having any other severe illness which may render the follow-up difficult
Persons not giving written consent for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the proposed study is to evaluate the efficacy and safety of Saroglitazaar magnesium 4mg along with standard of care (SOC) in the treatment of Metabolic Associated Steatotic Liver Disease (MASLD) |
1 month , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of the proposed study is to evaluate the efficacy of Saroglitazaar magnesium 4mg on blood glucose levels, blood lipid levels and liver function tests (LFT). |
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dineshharshaclinic@gmail.com].
- For how long will this data be available start date provided 29-05-2024 and end date provided 28-05-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
A multicentric, prospective open-labeled trial to assess the efficacy and safety of Saroglitazaar magnesium 4mg along with Standard of Care in treating Metabolic Associated Steatosis Liver Disease. A 6-month prospective study will be done on persons diagnosed with metabolic-associated Steatotic liver disease also called as nonalcoholic fatty liver disease using Velocity controlled transient elastography also called Fibroscan. The persons having Steatosis stage 3 or fibrosis stage 2 or more will be prescribed the study drug and followed up for 6 months. The primary objective of the study is to see the efficacy of the drug in these patients and the secondary objective is to see the change in glycemic parameters, lipid parameters, and liver function test. We would also keep a watch on the adverse events, if any, associated with the drug. |