| CTRI Number |
CTRI/2019/05/019168 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the reduction in blood pressure benefits of 2 drugs Azilsartan and Cilnidipine in sugar patients. |
|
Scientific Title of Study
|
A clinical study to compare the antihypertensive benefits of Cilnidipine & Azilsartan in T2DM patients. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Shameemunisha |
| Designation |
MD Pharmacology 1st year Post Graduate Department of Pharmacology |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Post Graduate Room
Department of Pharmacology
PSG Institute of Medical Sciences And Research Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
919790962881 |
| Fax |
|
| Email |
shameemnoor93@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head Of The Department of Pharmacology |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Professor and HOD Room
Department of Pharmacology
PSG Institute of Medical Sciences And Research
peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
919894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head Of The Department of Pharmacology |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Professor and HOD Room
Department of Pharmacology
PSG Institute of Medical Sciences And Research
peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
919894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
PEELAMEDU
COIMBATORE 641004
TAMILNADU |
|
|
Primary Sponsor
|
| Name |
Dr SHAMEEMUNISHA |
| Address |
POST GRADUATE ROOM
DEPARTMENT OF PHARMACOLOGY
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
PEELAMEDU
COIMBATORE 641004 |
| 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 M SHAMEEMUNISHA |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
PROFESSOR ROOM,DEPARTMENT OF MEDICINE AND PG ROOM,DEPARTMENT OF PHARMACOLOGY
Coimbatore
TAMIL NADU |
919790962881
shameemnoor93@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee PSGIMS&R |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CILNIDIPINE |
TO STUDY THE ANTIHYPERTENSIVE BENEFIT OF CILNIDIPINE AND AZILSARTAN IN TYPE 2 DIABETES MELLITUS PATIENTS RENAL AND CARDIA OUTCOME |
| Comparator Agent |
TABLET AZILSARTAN 40MG OD FOR 3 MONTHS |
TO STUDY THE ANTIHYPERTENSIVE BENEFIT OF CILNIDIPINE AND AZILSARTAN IN TYPE 2 DIABETES MELLITUS PATIENTS RENAL AND CARDIA OUTCOME |
| Comparator Agent |
TABLET CILNIDIPINE 5-10MG OD FOR 3 MONTHS |
TO STUDY THE ANTIHYPERTENSIVE BENEFIT OF CILNIDIPINE AND AZILSARTAN IN TYPE 2 DIABETES MELLITUS PATIENTS RENAL AND CARDIA OUTCOME |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Type 2 Diabetes Mellitus > 2years duration on medical treatment with newly diagnosed Simple Hypertension (JNC8)
2.Male and Female
3.Age >40 years
4.Outpatient from Department of General Medicine.
5.BMI up to type I obesity (30-40)
6.All DM patients on OHA either single /double/triple/insulin
|
|
| ExclusionCriteria |
| Details |
1.Renal dysfunction,
2.Patients on NSAIDS, STATIN, ASPIRIN, Immunomodulators , alternative medicines
3.Hepatic dysfunction
4.Cardiac abnormalities
5.Pregnancy and lactating women
6.Inpatients
7.ICU patients
8.EMD patients
9.Serious infections
10.PVD
11.H/o Smoking,Alcohol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the antihypertensive benefit of Azilsartan and Cilnidipine in type 2 diabetes hypertensive patient’s cardiac and renal parameters
|
PREMEDICATION PARAMETERS FBS,PPBS,hsCRP,eGFR,BP,BMI,LIPID PROFILE- WILL BE DONE 1 DAY PRIOR TO INITIATING MEDICATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Azilsartan and Cilnidipine protective effects on cardiac(hsCRP) and renal risk factors (eGFR)
|
POST MEDICATION PARAMETERS FBS,PPBS,hsCRP,eGFR,BP,BMI,LIPID PROFILE- AFTER 3 MONTHS OF MEDICATION PERIOD 1 DAY LATER PARAMETERS WILL BE DONE |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/06/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: Hypertension is the commenest cardiovascular disease and one of the cause of mortality and morbidity in human population. among many risk factors systemic hypertension is present in more than 50% of Diabetes mellitus patients and contributes significantly to micro and macrovascular disease in Diabetes mellitus,among many risk factor for cardiovascular disease hypertension is most prevalent one and it can be diagnosed and treated easily by medication and life style modification. This study aimed to find out the antihypertensive benifit, cardiac and renal outcome of ARB and calcium channel blockers in patients with type 2 DM with newly diagnosed hypertension of age more than 40 years. Materials and methodology: sample size of 64 patients in 2 groups(32/group) will be randomly assigned through simple randomization to treat with Azilsartan(40mg) and Cilnidipine(5-10mg) for a period of 3 months. Baseline parameters like FBS,PPBS,hsCRP,HBA1C,BP,BMI,eGFR, Lipid profile will be done before initiation of treatment, and same parameters will be done after 3 months of the study period. This study is focused to find out both Azilsartan and Cilnidipine potential to alter baseline BP, hsCRP, eGFR outcome. Result: Data collection will be statistically analyzed by paired and unpaired t TEST. Conclusion: This study may provide new insight to the clinical use of Calcium channel blocker Cilnidipine in diabetic hypertensive patients IHEC approval: This study has been approved by the IHEC of PSG Institute of Medical Sciences and Research(Affliated to TN MGR Medical University), coimbatore-Proposal number.18/346,dated 19/02/2019 |