| CTRI Number |
CTRI/2024/10/074541 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Rosuvastatin with Rosuvastatin plus zinc in improving serum lipid levels among dyslipidemia patients. |
|
Scientific Title of Study
|
A comparative evaluation of safety and efficacy of Rosuvastatin with and without Zinc as an adjuvant in pharmacotherapy of dyslipidemia in tertiary care Hospital, Kanpur (U.P) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Singh |
| Designation |
PhD STUDENT |
| Affiliation |
RAMA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Department of pharmacology,
Rama Medical College Hospital and Research Centre,
Mandhana,
Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
09792262232 |
| Fax |
|
| Email |
mahimasingh.kmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NILAM NIGAM |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
RAMA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Department of pharmacology,
Rama Medical College Hospital and Research Centre,
Mandhana,
Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
09140190476 |
| Fax |
|
| Email |
drnilamnigam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Singh |
| Designation |
PhD STUDENT |
| Affiliation |
RAMA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Department of pharmacology,
Rama Medical College Hospital and Research Centre,
Mandhana,
Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
09792262232 |
| Fax |
|
| Email |
mahimasingh.kmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rama Medical College Hospital and Research Centre, Mandhana, Kanpur Nagar, Uttar Pradesh-209217, India |
|
|
Primary Sponsor
|
| Name |
Mahima Singh |
| Address |
Department of pharmacology,
Rama Medical College Hospital and Research Centre,
Mandhana,
Kanpur,
uttar Pradesh-209217
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 |
| Mahima Singh |
Rama Medical College Hospital and Research Centre |
Room no: 02158, Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur Nagar, Uttar Pradesh-209217, India
Kanpur Nagar
UTTAR PRADESH |
9792262232
mahimasingh.kmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rama Medical College Hospital and Research Centre |
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 |
Rosuvastatin |
Rosuvastatin 10mg oral tablet OD for 12 weeks |
| Intervention |
Rosuvastatin and Zinc |
Rosuvastatin10 mg and Zinc 25 mg OD orally for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having serum LDL cholesterol above 130mg/dl, Serum triglycerides above or equal to 150mg/dl and less than or equal to 500mg/dl. Patients who are able to adequately maintain diary. Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF |
|
| ExclusionCriteria |
| Details |
Fasting serum triglyceride (TG) level above 500 mg/dl, Medical history of systemic infection within 6 weeks of study initiation, Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study, Uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg), Uncontrolled diabetes mellitus (FBS above 300 mg/dl in patients with diabetes), ALT and AST greater than 2x upper limit of normal, Impaired renal function (creatinine greater than or equal to 2.0 mg/dl), Suffering from malabsorption syndrome or inflammatory bowel disease, Pregnancy/Lactation, Alcoholism, Patients on drugs that can increase the incidence of statin induced myopathy, Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy in achieving target LDL-C and triglyceride levels |
6 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish the patient characteristics based upon baseline data with dyslipidemia in Kanpur, UP population
Incidence of any adverse drug reaction will be reported at Timepoints-every 2 week for12 weeks
Changes Serum HDL-c levels at Timepoints-every 2 week for12 weeks
Patient compliance
|
Baseline, 6 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="410"
Sample Size from India="410"
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 4 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mahimasingh.kmc@gmail.com].
- For how long will this data be available start date provided 03-12-2025 and end date provided 03-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, open labeled, parallel group, single- centre trial comparing the efficacy and safety of rosuvastatin 10 mg daily with and without zinc25mg for 12 weeks in 410 patients with Dyslipidemia that will be conducted in a tertiary care hospital, Kanpur, India. The primary outcome measures will be achieving target lipid profile during 6 weeks and 12 weeks of study period. The secondary outcomes will be evaluation of baseline data characterization, HDL-C variation, adverse events and patient compliance of the treatment at 6 and 12 weeks of study period. |