| CTRI Number |
CTRI/2024/01/061941 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Atorvastatin and Rosuvastatin on Lipid Profile and Vitamin D concentration in patients with abnormal lipid level. |
|
Scientific Title of Study
|
A comparative study to evaluate the impact of Atorvastatin versus Rosuvastatin on the Lipid profile and Vitamin D concentration in Dyslipidemic patients of eastern Uttar Pradesh 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 Ashutosh Roy |
| Designation |
Junior Resident |
| Affiliation |
B R D Medical College |
| Address |
3rd Floor, Department of Pharmacology, B R D Medical College, Gorakhpur.
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9838331896 |
| Fax |
|
| Email |
ashuroy0107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
B R D Medical College |
| Address |
3rd Floor, Department of Pharmacology, B R D Medical College, Gorakhpur.
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
B R D Medical College |
| Address |
3rd Floor, Department of Pharmacology, B R D Medical College, Gorakhpur.
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, B R D Medical College, Gorakhpur, Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Dr Ashutosh Roy |
| Address |
3rd Floor, Department of Pharmacology, B R D Medical College, Gorakhpur, Uttar Pradesh-273013 |
| 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 Ashutosh Roy |
Baba Raghav Das Medical College |
Department of Pharmacology
Gorakhpur
UTTAR PRADESH |
9838331896
ashuroy0107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College research council, B R D 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 |
| Comparator Agent |
Atorvastatin |
20 mg OD for 3 months |
| Intervention |
Rosuvastatin |
10 mg OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving written informed consent for the study.
Both genders.
All patients 25 years of age with dyslipidaemia not meeting the goal for LDL-C, according to the European Society of Cardiology (ESC) and the European Atherosclerosis Society guidelines for the management of dyslipidaemias.
All adult patients age (25-65 years) willing to take medication as directed and ready to come for the follow up. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Base line, 1st month, 2nd month, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid profile, Vitamin D Concentration, Adverse drug reaction. |
Every month for 3 month |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
31/01/2024 |
| 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="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
|
A prospective randomized parallel group , open label drug trial to evaluate the effect of Atorvastatin versus Rosuvastatin on the Lipid profile and vitamin D concentration along with observing the side effects of both the drugs in patients with Dyslipidemia. |