Hypertensive Heart Disease
Conditions
Interventions
This is a two-arm, randomized, placebo-controlled, double-blind, two-month, phase 1, non-inferiority clinical trial with a non-inferiority design to evaluate the safety of the herbal drug *A. polystac
Sponsors
Universidade de Ribeirão Preto - UNAERP
Universidade de Ribeirão Preto - UNAERP
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Men, non-pregnant women. Age greater than 18 years and less than or equal to 80 years. Diagnosis of hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg) and on at least monotherapy for this disease and with good blood pressure control in the last month (assessed by interview and initial blood pressure measurement)
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women. Individuals with secondary systemic arterial hypertension. Individuals with paroxysmal or permanent atrial fibrillation. Individuals using any other herbal medicine during the study. Individuals experiencing a serious adverse reaction to the medication such as anaphylaxis, severe hypotension, significant abnormalities in biochemical or hematological tests. Individuals with a BMI greater than or equal to 35. Individuals requesting to be withdrawn from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The herbal drug is expected to have a safe effect on hypertensive patients undergoing conventional treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The herbal drug is expected to have a safe effect on hypertensive patients undergoing conventional treatment. | — |
Countries
Brazil
Contacts
Public ContactClaudia Domingos
Universidade de Ribeirão Preto - UNAERP
Outcome results
None listed