| CTRI Number |
CTRI/2025/02/080230 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out how well Saroglitazar helps improve fatty liver disease and manage related problems like high cholesterol, blood sugar, and weight in people with metabolic syndrome. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Saroglitazar in the management of Non-alchoholic fatty liver in patients with Metabolic Syndrome-A Prospective Interventional Study |
| 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 S Sarumathy MPharm PhD |
| Designation |
Associate professor |
| Affiliation |
SRM, College of Pharmacy, SRMIST |
| Address |
Room no 4, J block, 4th floor, Department of pharmacy practice, SRM medical college hospital and research centre .
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010530419 |
| Fax |
|
| Email |
sarumats@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nanda Kumar MBBS MD |
| Designation |
Professor |
| Affiliation |
SRM, Medical college ,SRMIST |
| Address |
Room no 7,H block ,Department of General medicine,SRM hospital and research centre,SRM institute of science and technology, kattankulathur, chengalpattu district, 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
8939824713 |
| Fax |
|
| Email |
nandy.ramachandran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T M Vijaykumar |
| Designation |
Professor and head |
| Affiliation |
SRM, College of Pharmacy, SRMIST |
| Address |
Room no 2, J block , 4th floor, department of pharmacy practice, SRM Medical college hospital and research centre.
Chennai
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER , GENERAL MEDICINE OUTPATIENT , POTHERI, CHENGALPATTU -603203
TAMIL NADU, INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| HUBERT IGNO CASTUS |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Room no 3, J block , 4th floor, department of pharmacy practice, SRM Medical college hospital and research centre,
Kancheepuram
TAMIL NADU |
6380873395
hubertcastus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
SAROGLITAZAR
|
DOSE- 4MG (TABLET)
FREQUENCY- OD
DURATION- 45 DAYS
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both gender and aged above 18 to 75 years.
2. A diagnosis of NAFLD established by fibro scan.
Body mass index more than 25 kg per meter square
Stable body weight change less than plus or minus 10 percentage of body weight for 3 months before the study.
3. Central obesity: Waist circumference 90 cm or greater in men or 80 cm or greater in women
Elevated fasting plasma glucose: fasting plasma glucose of 100 mg per dL or greater or HBA1c greater than 6.5 percentage
4. Patients with Elevated triglycerides serum triglycerides 150 mg per dL or greater or Reduced high-density lipoprotein cholesterol serum HDL-c less than 40 mg per in men or less than 50 mg per dL in women; or Elevated blood pressure systolic blood pressure of 130 mmHg or greater or diastolic blood pressure of 85 mmHg or greater are included.
5. Patients who are able and willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Metabolic syndrome patients with HbA1c greater than 9 percent and or use of thiazolidinediones like pioglitazone, rosiglitazone, CYP2C8 inhibitors , fibrates like clofibrate, fenofibrate.
2. Patients having vitamin E greater than 100 IU per day administration, or multivitamins containing greater than 100 IU per day of vitamin E in the 3 months prior to the screening visit.
3. Patients with known cardiovascular and cerebrovascular diseases like coronary heart disease, stroke, or revascularization and malignant tumours.
4. Patients having other chronic liver disease and established diagnosis of cirrhosis .
5. Patient with acute or chronic viral infection within the previous 4 weeks.
6. Alcohol abuse of weekly consumption of alcohol is more than 70 g in women or 140 g in men. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Efficacy of SAROGLITAZOR in controlling fatty liver progression and rapid recovery from symptoms.
The change in CAP SCORE from GRADE 1 (5 - 33 percentage) to normal (less than 5 percentage)
|
DAY 1 ( BASELINE VALUE)
DAY 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the metabolic syndrome severity score saroglitazar 4mg before and after administration.
To check body weight, waist hip ratio, blood pressure, glycemic control
To find out, incidence of adverse events during the study period
|
DAY 1 ( BASELINE VALUE)
DAY 45 |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
17/02/2025 |
| 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)
|
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
|
|