| CTRI Number |
CTRI/2022/10/046795 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study sugar lowering and cholesterol lowering effects of T. Saroglitazar in patients with abnormal Sugar and Cholesterol |
|
Scientific Title of Study
|
Study on antidyslipidemic and insulin sensitising effects of saroglitazar in patients with diabetic dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini chawla |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Room number 117
Dept of pharmacology
Pathology block
Maulana Azad medical college
Bahadur shah Zafar marg
Near Delhi gate
2, Bahadur shah Zafar marg
Near Delhi gate
New Delhi- 110002
New Delhi
DELHI
110002
India |
| Phone |
9968604284 |
| Fax |
|
| Email |
drshalinichawla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balakumar |
| Designation |
Junior resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Room number 162
Department of pharmacology
Pathology block
Maulana Azad medical college
2, Bahadur shah Zafar marg
Near Delhi gate
New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8148782997 |
| Fax |
|
| Email |
bala7595@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balakumar |
| Designation |
Junior resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Room number 162
Department of pharmacology
Pathology block
Maulana Azad medical college
2, Bahadur shah Zafar marg
Near Delhi gate
New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8148782997 |
| Fax |
|
| Email |
bala7595@gmail.com |
|
|
Source of Monetary or Material Support
|
| maulana azad medical college
Bahadur shah zafar marg
Near Delhi Gate
New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
maulana azad medical college |
| Address |
bahadur shah zafar marg,
new delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 K E Balakumar |
maulana azad medical college |
room number 162
Pathology Block,
Maulana azad medical college
Bahadur shah zafar marg
New Delhi - 110002
New Delhi
DELHI |
8148782997
bala7595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE, MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diabetic dyslipidemia with fasting triglycerides > 200-400 who are being treated with any of non insulin secretogogues( alpha glucose daze inhibitors, biguanides, SGLT-2 inhibitors) and low dose statin for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
patients on insulin, glitazar, glitazone, insulin secretogagues (sulfonylureas)
history of Thyroid disease, cardiac illness, liver disease (s.bilirubin > 2 times Upper normal limits), renal dysfunction(s.creatinine > 1.2mg/dL)
comorbid serious illness like tuberculosis, malignancy, HIV.
Pregnant and nursing mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effects of Saroglitazar on
1. Insulin Resistance
2. Lipid profile
in patients with Diabetic Dyslipidemia
|
0 and 84th day after drug intake |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
study the effects of Saroglitazar on
1. HbA1c levels
2. Body weight
3. Safety profile in patients with Diabetic Dyslipidemia.
|
0 and 84th day of drug intake |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
10/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Saroglitazar is a Dual PPAR agonist approved for use in treatment of diabetic dyslipidemia animal model studies indicated that saroglitazar has a role in improving insulin sensitivity we are going to see the effect of saroglitazar in terms if insulin sensitivity (by neasurement of HOMA-IR) and lipid profile in patients of Diabetic dyslipidemia with low dose statins |