| CTRI Number |
CTRI/2024/06/068921 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating The desired effect Of the drug Imeglimin In Patients With Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
A Double Blind Randomized Placebo Controlled Pilot Study Evaluating The Efficacy Of Imeglimin In Patients With Polycystic Ovarian Syndrome |
| 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. Riya Sharma |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University ,Medical College road ,AMU campus ,Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8875774424 |
| Fax |
|
| Email |
riyasharma121097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Waseem Rizvi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of pharmacology
Jawaharlal Nehru Medical College Aligarh Muslim University ,Medical College road ,AMU campus ,Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897686003 |
| Fax |
|
| Email |
waseemnakhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Waseem Rizvi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College Aligarh Muslim University |
| Address |
Department of pharmacology
Jawaharlal Nehru Medical College Aligarh Muslim University ,Medical College road ,AMU campus ,Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897686003 |
| Fax |
|
| Email |
waseemnakhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Aligarh Muslim University, Medical College road ,AMU campus ,Civil lines ,ALIGARH ,Pincode-202002 ,Uttar pradesh ,India |
|
|
Primary Sponsor
|
| Name |
Riya Sharma self |
| Address |
Jawaharlal Nehru Medical College Aligarh Muslim University, Medical college road ,AMU campus ,civil lines Aligarh , Uttar pradesh-202002 India |
| 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 |
| Dr Riya Sharma |
Jawaharlal Nehru Medical college and hospital |
Departments of Pharmacology , Obstetrics & Gynaecology and Diabetes and Endocrinology Jawaharlal Nehru medical college Aligarh muslim university ,medical college road , AMU campus , Civil Lines ,Aligarh 202002
Aligarh
UTTAR PRADESH |
8875774424
riyasharma121097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Regd.) ,Jawaharlal Nehru medical college and hospital ,Faculty of medicine Aligarh Muslim university ,Aligarh U.P ,India ,202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin and Imeglimin |
Metformin 500mg OD with imeglimin 500mg OD for 6 months |
| Comparator Agent |
Metformin with placebo |
Metformin 500 mg OD with Placebo OD for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
-Polycystic ovarian syndrome diagnosed patient with BMI ≥ 25 kg/m2
-Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
-History of allergic reactions attributed to compounds of similar chemical or biologic composition of metformin or imeglimin
-Patients with history renal dysfunction (documented in biochemical test), acute / chronic metabolic acidosis, congestive cardiac failure needing drug treatment, lactic acidosis
-Patients on drug known to have significant drug-drug interactions either metformin or imeglimin
-Pregnant females
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for insulin resistance (HOMO-IR) |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Hyperandrogenism using S.Testosterone
- Inflammation using AGEs, MDA,CRP
- ADRs in both arm using WHO-UMC Causality assessment scale
- Quality of life of polycystic ovarian syndrome patients will be assessed using a questionnaire
|
Two years |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="2"
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
|
A Double Blind Randomized Placebo Controlled Pilot Study Evaluating The Efficacy Of Imeglimin In Patients With Polycystic Ovarian Syndrome with BMI more than 25mg/kg2 . For the study, A total of 100 patients are taken. They will be equally divided into two groups .One group will receive Metformin 500mg OD with placebo for 6months and other group will receive Metformin 500mg OD with imeglimin 500mg OD for 6months .The primary outcome measures Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for insulin resistance (HOMO-IR). |