Human studies to evaluate the effect and safety of passion fruit peel extract on reducing high blood pressure

Clinical phase II assessment to assess the effectiveness, safety and tolerability of the peel extract of Passiflora edulis in the reduction of blood pressure in patients with Arterial Hypertension stage I

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-42nhd6

Enrollment

Unknown

Registered

2019-10-25

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential (primary) hypertension

Interventions

At pre-inclusion 16 participants will initiate a run-in period with placebo, one capsule 2 times a day, for 2 weeks. Participants who maintained diastolic and systolic blood pressure values, measured

Drug

B01.650.560

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
As a primary outcome a mean 24h diastolic pressure reduction is estimated as measured by MAPA.	—

Secondary

Measure	Time frame
As a secondary outcome, a reduction is expected of the daytime diastolic pressure evaluated by MAPA and the nocturnal diastolic pressure assessed by MAPA.	—

Countries

Brazil

Contacts

Public ContactSilvana Maria;Silvana Langassner ;Langassner

Universidade Federal do Rio Grande do Norte;Universidade Federal do Rio Grande do Norte

szucolotto@hotmail.com;barbara_cabral01@hotmail.com55-84-81160002;84 81160002

Outcome results

None listed

Source: REBEC (via WHO ICTRP)