| CTRI Number |
CTRI/2024/08/071848 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Response to treatment with two different drugs ( Dapagliflozin and Saroglitazaar ) in patients fatty liver and liver fibrosis |
|
Scientific Title of Study
|
A 25-week Multicentric Prospective Open Labelled Trial Comparing the Safety and Efficacy of Saroglitazaar Magnesium 4mg with Dapagliflozin Propanediol Monohydrate 10mg along with Standard of Care in the Treatment of Metabolic Associated Steatotic Liver Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCDC/04/2023 VERSION 01 DATE : 15-08-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Kumar |
| Designation |
MBBS MD |
| Affiliation |
HARSHA CLINIC AND DIABETES CENTRE |
| Address |
Harsha Clinic and Diabetes Centre
555Cha 160B,
Singar Nagar, Kanpur Road, Lucknow
555Cha,
160B, Singar Nagar, Kanpur Road
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
7355389642 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Dinesh Kumar |
| Designation |
MBBS MD |
| Affiliation |
HARSHA CLINIC AND DIABETES CENTRE |
| Address |
Harsha Clinic and Diabetes Centre,
555Cha, 160B, Singar Nagar, Kanpur Road, Lucknow
555Cha, 160B, Singar Nagar, Kanpur Road
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
7355389642 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DINESH KUMAR |
| Designation |
MBBS MD |
| Affiliation |
HARSHA CLINIC AND DIABETES CENTRE |
| Address |
Harsha Clinic and Diabetes Centre, 555Cha, 160B, Singar Nagar, Kanpur Road, Lucknow
555Cha, 160B, Singar Nagar, Kanpur Road
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
7355389642 |
| Fax |
|
| Email |
dineshharshaclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR DINESH KUMAR,
Harsha Clinic and Diabetes
Centre
555Cha, 160B, Singar Nagar, Kanpur Road, Lucknow, India, 226005 |
|
|
Primary Sponsor
|
| Name |
DR DINESH KUMAR |
| Address |
Harsha Clini and Diabetes Centre, 555Cha 160B Singar Nagar,Lucknow |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR K P CHANDRA |
CHANDRA DIABETES AND HEART CLINIC |
Department of Medicine room number 3,
D-4/658 VIJAYANT KHAND GOMTI NAGAR 226010
Lucknow
UTTAR PRADESH |
780092222
drkpchandra@gmail.com |
| DR DINESH KUMAR |
HARSHA CLINIC AND DIABETES CENTRE |
555CHA 160B SINGAR NAGAR KANPUR ROAD
Lucknow
UTTAR PRADESH |
7355389642
dineshharshaclinic@gmail.com |
| DR RAJIV AWASTHI |
PRARTHANA CLINIC AND DIABETES CARE CENTRE |
Deaprtment of Medicine,
Room number 2
510,179 NEW HYDERABAD HASANGANJ, 226007
Lucknow
UTTAR PRADESH |
9838281506
rajiv.max@gmail.com |
| DR MUKULESH GUPTA |
UDYAAN HEALTH Centre PVT LTD |
Department of Medicine , Room number 2
730, UDYAN 1 ELDECO NEAR BANGLA BAZAAR 226012
Lucknow
UTTAR PRADESH |
9336046146
drmukulesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Udyaan Healthcare |
Approved |
| Institutional Human Ethics Committee Udyaan Healthcare |
Approved |
| Institutional Human Ethics Committee Uyaan Healthcare |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dapagliflozin Propendiol Monohydrate 10mg |
Compare the safety and efficacy of Dapagliflozin Propendiol Monohydrate 10mg with Saroglitazaar Magnesium 4mg in the treatment of Metabolic Associated Steatotic liver Disease for duration of 6 months |
| Intervention |
Saroglitazaar Magnesium 4mg |
Safety and efficacy of Saroglitazaar Magnesium 4mg in the treatment of Metabolic Associated Steatotic Liver Disease for duration of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A diagnosis of MASLD/NAFLD established by Vibration Controlled Transient Elastography using FIBROSCAN.
All persons with grade 3 fatty liver and F2 -F4 liver fibrosis on Fibroscan |
|
| ExclusionCriteria |
| Details |
Persons with known cirrhosis of liver
persons with T1DM
Persons taking alcohol in quantity more than allowed
Persons already taking thiozolidedinediones, Vitamin E and SGLT2 inhibitors.
Persons taking alcohol in a quantity more than the standard limits set by aasld (Asia PACIFIC region)
Persons having positive HBsAg and anti-HCV
Persons with other causes of liver diseases e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease
Persons on steatogenic drugs like amiodarone, methotrexate, oral contraceptives, and glucocorticoids.
Pregnant and Lactating females
Persons having underlying diseases like acute viral hepatitis, congestive hepatomegaly, or billiary congestion which can disturb the estimation done by fibro scan
Persons having Hepatocellular Carcinoma
Persons having known allergy to saroglitazaar magnesium
Persons having any other severe illness that may render the follow-up visits 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 |
| To see the improvement in liver steatosis and liver fibrosis in response to Saroglitazaar Magnesium 4mg or Dapagliglozin propendiol Monohydrate 10mg |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the improvement in Liver Function Test |
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)
|
02/09/2024 |
| 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
|
A 25-week multicentric prospective trial to compare the efficacy of Saroglitazaar Magnesium 4mg with Dapagliflozin Propendial Monohydrate 10mg along with the standard of care in persons with Metabolic Associated Steatotic Liver Disease. Persons with Grade 3 fatty liver or stage 2 liver fibrosis on Fibroscan will be put on either of the two drugs based on the discretion of the treating physician. The participants will be followed up for 6 months and repeat Fibroscan will be done . the response to the two drugs will be recorded and compared for safety and efficacy |