Human studies to evaluate the effect and safety of passion fruit peel extract on reducing high blood pressure
- Conditions
- Essential (primary) hypertension
- Registration Number
- RBR-42nhd6
- Lead Sponsor
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
both sexes; age between 18 and 60 years; distolic arterial pressure between 90 and 99 mmHg in the mean of two measurements with a 5-minute interval in the sitting position on the right brachial artery using a sphygmomanometer; systolic blood pressure lower than 160 mmHg; never had treatment for hypertension; agree to participate in the study with the signature of the TCLE
secondary hypertension; diagnosis of fasting diabetes or glycemia greater than 120 mg/dL; kidney disease with creatinine> 2 times the upper limit of normal; obesity defined by a body mass index> 30 kg / m2; endocrine diseases (hyperaldosteronism, hypercortisolism, hyperthyroidism, pheochromocytoma); liver disease with ALT or AST> 2 times the upper limit of normal; peptic ulcer in the last 3 months; severe respiratory failure; hemorrhagic disease; Neoplasia and user of intravenous substances; pregnant or nursing women
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As a primary outcome a mean 24h diastolic pressure reduction is estimated as measured by MAPA.
- Secondary Outcome Measures
Name Time Method As a secondary outcome, a reduction is expected<br>of the daytime diastolic pressure evaluated by MAPA and the nocturnal diastolic pressure assessed by MAPA.