| CTRI Number |
CTRI/2024/07/070696 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and effectiveness of rosuvastatin versus rosuvastatin with fenofibrate in patients with dyslipidemia. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of rosuvastatin or in combination of rosuvastatin with fenofibrate in patients with dyslipidemia at tertiary care centre. |
| 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 Shivam Yadav |
| Designation |
Junior Resident |
| Affiliation |
Baba Raghav Das Medical College, Gorakhpur |
| Address |
3rd Floor, Department Of Pharmacology, Gorakhpur, BRD Medical College, Gorakhpur, Uttar Pradesh India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9651701212 |
| Fax |
|
| Email |
shivamyadav.mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Baba Raghav Das Medical College, Gorakhpur |
| Address |
3rd Floor, Department Of Pharmacology, Gorakhpur, BRD Medical College, Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Yadav |
| Designation |
Junior Resident |
| Affiliation |
Baba Raghav Das Medical College, Gorakhpur |
| Address |
3rd Floor, Department Of Pharmacology, Gorakhpur, BRD Medical College, Gorakhpur, Uttar Pradesh India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9651701212 |
| Fax |
|
| Email |
shivamyadav.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, Baba Raghav Das Medical College, Gorakhpur, Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Dr Shivam Yadav |
| Address |
Room No.29 Old PG. Hostel BRD Medical College, Gorakhpur, Uttar Pradesh 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 Shivam Yadav |
Baba Raghav Das Medical College |
Department Of Pharmacology, Gorakhpur, BRD Medical College, Gorakhpur, Uttar Pradesh India
Gorakhpur
UTTAR PRADESH |
09651701212
shivamyadav.mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Research Council BRD Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
R0SUVASTATIN and FENOFIBRATE |
10 mg and 160 mg respectively for 3 months |
| Comparator Agent |
ROSUVASTATIN |
10 mg for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Either gender aged 18 to 70 years .
Patients giving written informed consent will be taken.
Hypertensive patients. |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the study.
Active liver disease.
Preexisting gallbladder disease.
Type 1 diabetes mellitus.
Thyroid dysfunction.
Type 2 diabetes mellitus.
Any malignancies.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline, 2 months, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction |
At 2nd and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
26/07/2024 |
| 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="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
|
A Prospective randomized parallel group interventional study to compare efficacy and safety of Rosuvastatin alone or in combination with Fenofibrates in patients with Dyslipidemia. |