| CTRI Number |
CTRI/2023/11/059677 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
01/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population |
|
Scientific Title of Study
|
Randomised Open Label Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARSH GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IMS and SUM hospital |
| Address |
Q207, Trident Galaxy, Kalinga Nagar, Bhubaneswar, Odisha
Discussion room (near opd), ground floor, Department of general medicine, ims and sum hospital, K8, Kalinga Nagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9416677041 |
| Fax |
|
| Email |
arshgupta09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandan Das |
| Designation |
Professor , department of general medicine |
| Affiliation |
IMS and SUM hospital |
| Address |
Department of general medicine fourth floor, Ims and Sum Hospital, K8, Kalinga nagar
Bhubaneswar, Odisha
India
Khordha
ORISSA
751003
India |
| Phone |
9937063390 |
| Fax |
|
| Email |
drchandan1204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARSH GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IMS and SUM hospital |
| Address |
Q207, Trident Galaxy, Kalinga Nagar, Bhubaneswar, Odisha
Discussion room (near opd), ground floor, Department of general medicine, ims and sum hospital, K8, Kalinga Nagar, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9416677041 |
| Fax |
|
| Email |
arshgupta09@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM HOSPITAL, Department of general medicine and Department of gastroenterology , K8, Kalinga Nagar, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Arsh gupta |
| Address |
Discussion room (near opd), ground floor, Department of general medicine, ims and sum hospital, K8, Kalinga Nagar, Bhubaneswar, Odisha
PIN CODE – 751003 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| ARSH GUPTA |
IMS AND SUM HOSPITAL |
Discussion room (near opd), ground floor, Department of general medicine, ims and sum hospital, K8, Kalinga Nagar, Bhubaneswar, Odisha
Khordha
ORISSA |
9416677041
ARSHGUPTA09@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K758||Other specified inflammatory liverdiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SAROGLITAZAR
(DIABETIC vs NON DIABETIC POPULATION) |
Patients of non alcoholic fatty liver disease will be divided among type 2 diabetic and non diabetic patients. Randomization will be done among both arms separately. After randomization study group will receive saroglitazar in both arms and other will be control group in both arms. |
| Intervention |
SAROGLITAZAR |
Dose- 4mg
Frequency- once daily
Route of administration- oral
Duration - 6 months
Patients with and without diabetes will be receiving saroglitazar. Effect of drug through various parameters will be studied in both arms after 6 moths and compared with the control group, then the effect will be compared within diabetic and non diabetic population. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of fatty liver on ultrasound
Patients with Type2DM
Patients without diabetes
|
|
| ExclusionCriteria |
| Details |
presence of chronic hepatitis B or C infection (positive Hbs Ag or anti HCV Ab) , significant alcohol intake (>20 gm/ day for males and >10 gm/day for females). Cases with a history of intake of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis ( obeticholic acid, vitamin E , pioglitazone, UDCA, omega fatty acid ) , documented cases of autoimmune hepatitis, hepatic storage disorders such as hemochromatosis and Wilson’s disease will be excluded. Patients having others co-morbidities like hypothyroidism, ischemic heart disease or chronic kidney disease will not be included. Pregnant patient will not be included. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver Stiffness measurement score by Fibroscan |
once before initition of drug and once after completion of 6 months course of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SGOT
SGPT
TPC
APRI
FIB 4
NAFLD FIBROSIS SCORE |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/11/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim:
TO COMPARE THE EFFECT OF SAROGLITAZAR ON STEATOSIS AND
FIBROSIS IN NON ALCOHOLIC FATTY LIVER DISEASE WITH TYPE 2 DIABETES MELLITUS
AND NON DIABETIC POPULATION.
Objective:
To evaluate and compare the effect
of Saroglitazar in patients of non alcoholic fatty liver disease with and
without diabetes.
Drug :
Saroglitazar is the only
drug approved by DCGI with permission Number: MF/SND/20/000376 dated
28-Dec-2020 to treat Non-Alcoholic Fatty Liver Disease (NAFLD) with associated
co morbidities such as obesity, type 2 diabetes mellitus (DM), dyslipidemia,
or, Metabolic Syndrome (MS), improves insulin sensitivity and lipid oxidation
by acting on PPAR-γ and PPAR-α respectively.
Patients of NAFLD will be divided among diabetic and non diabetic population. The patients of both the arms will be randomised separately into study and control group. The study group of both arm will receive saroglitazar 4mg for 6 months and the effect will be compared with the control group , and effect of sarogltazar will also be compared within diabetic and non diabetic population.
|