A study to compare the reduction in blood pressure benefits of 2 drugs Azilsartan and Cilnidipine in sugar patients.

Phase 2

Completed

Registration Number: CTRI/2019/05/019168

Lead Sponsor: Dr SHAMEEMUNISHA

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the antihypertensive benefit of Azilsartan and Cilnidipine in type 2 diabetes hypertensive patientâ€™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 Measures

Name	Time	Method
To compare Azilsartan and Cilnidipine protective effects on cardiac(hsCRP) and renal risk factors (eGFR)

Trial Locations

Locations (1): PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
🇮🇳
Coimbatore, TAMIL NADU, India
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
🇮🇳Coimbatore, TAMIL NADU, India
Dr M SHAMEEMUNISHA
Principal investigator
919790962881
shameemnoor93@yahoo.com