Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Phyllanthus emblica extract: Phyllanthus emblica extract 500 mg twice daily plus (tablet amlodipine 5mg once daily or enalapril 5mg once daily) for 3 months
Control Intervention1: Ident
Sponsors
JIPMER Puducherry
Eligibility
Inclusion criteria
Inclusion criteria: Patients with essential hypertension aged >= 18 years, irrespective of gender, who meet any one of the following criteria 1.Newly diagnosed and started on amlodipine 5 mg or enalapril 5 mg 2.Already on treatment with stable dose of amlodipine 5 mg or enalapril 5 mg for atleast 1 month and has not yet attained target blood pressure goals (130 mmHg of systolic and 80 mmHg of diastolic blood pressure) and not requiring dose escalation or addition of second anti-hypertensive agent according to clinical judgment of the treating physician
Exclusion criteria
Exclusion criteria: 1. Patients with secondary hypertension 2. Patients with systolic BP >160 mmHg and diastolic BP >100 mmHg 3. Patients with hypertensive urgency/ emergency 4. Patients receiving antihypertensive drugs other than amlodipine and enalapril 5. Patients not on stable dose of oral hypoglycemic drugs and/or insulin for past 1 month 6. Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures 7. Patients with hepatic impairment (elevated liver enzymes > 2 times upper normal limit) 8. Patients with renal impairment (S.Creatinine > 1.2 mg/dL) 9. Patients with history of coronary artery disease and peripheral vascular disease 10. Patients who had participated in other trials in the past three months. 11. Patients on herbal medications 12. Patients not willing to sign written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in systolic blood pressure from baseline at end of 3 monthsTimepoint: Mean reduction in systolic blood pressure from baseline at end of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in diastolic blood pressure, serum uric acid, HbA1c, liver function, lipid levels, hs-CRP, oxidant and anti-oxidant levels, pulse wave velocity at end of 3 monthsTimepoint: Mean change from baseline in diastolic blood pressure, serum uric acid, HbA1c, liver function, lipid levels, hs-CRP, oxidant and anti-oxidant levels, pulse wave velocity at end of 3 months | — |
Countries
India
Contacts
Public ContactDr Harivenkatesh Natarajan
JIPMER, Puducherry
Outcome results
None listed