Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
None listed
Sponsors
Dr Nagaraj Desai
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting with following criteria to be included in the study: 1. Male or female patients, age equal or >18 to equal or 2. Patients who have uncontrolled BP with monotherapy (SBP >140 & DBP >90 mmHg) 3. Treatment naïve patients diagnosed with stage 2 de novo hypertension as per ESC/ESH 2018 guidelines on hypertension management. 4. Patients who are prescribed combination therapy as part of routine clinical practice by the study investigator. 5. Patients willing to follow clinical study instructions and complete the patient diaries allotted to them. 6. Patients or Legally acceptable representative of patient willing to provide written informed consent for participation in the clinical study.
Exclusion criteria
Exclusion criteria: Patients meeting with following criteria to be excluded from the study: 1. Female patients who are pregnant or breast feeding. 2. Patients with known liver or kidney (patients who are diagnosed with stage 3 or more Chronic Kidney Disease) dysfunction. 3. Patients who are consuming Ayurvedic/Herbal medicines which are intended for management of hypertension. 4. Patients who are suspected of or known to have an intolerance to any of the drugs prescribed as combination therapy. 5. Presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcomes or continued participation of patient in the study. 6. Participation in another study concurrently or within 4 weeks prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving the target blood pressure at the end of the treatment with combination therapy or standard of care after 3 months. Timepoint: At the end of treatment (after 3 month of baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving the target blood pressure after 1 month and 2 months of treatment with combination therapy or standard of care. 2. Evaluation of ECG, Serum Creatinine, Serum Sodium, Serum Potassium, HbA1c, FPG, Cholesterol, Microalbuminuria, Urine Examination, at baseline and 3 months. 3. Percentage of patients who continue the treatment with combination therapy after completion of the clinical study. 4. Mean reduction of SBP & DBP after 3 months of treatment with combination therapy or standard of care. 5. Mean reduction of office/clinic postural blood pressure (sitting and standing position) after 3 months of treatment. 6. Effectiveness of combination therapy in daytime and evening blood pressure control as monitored through HBPM. 7. Quality of Life (Likert scale) monitoring of the patients who have initiated treatment with combination therapy or standard of care. 8. Treatment compliance monitoring through patient diaries.Timepoint: At baseline, after 1 month, 2 months and 3 months | — |
Countries
India
Contacts
Public ContactDr Nagaraj Desai
Namana Medical Centre
Outcome results
None listed