Olive Leaf Extracts in the Control of Hypertension (Atherolive)

University of Monastir

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hypertension

Treatments: Drug: atherolive-drug; Drug: Placebo Atherolive

Study type: Interventional

Funder types: Other

Identifiers

NCT05636826

ATHEROLIVE-HTA

Details and patient eligibility

About

This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

Patients over 18 years of age with:

Arterial hypertension (hypertension).

Full description

This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

All the population will benifit of a biological assessment which include:

Complete lipid profile, blood sugar, creatinine

one population will be randomized:

The population of patients with hypertension.

For patients in the hypertension group:

A blood pressure with holter will be carried out for 24 hours .

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 years of age with:

Arterial hypertension (hypertension)

Exclusion criteria

• . Exclusion criteria: None.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

atherolive-drug

Active Comparator group

Description:

The patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive) will be prescribed at a dose of 400 mg, once a day for 3 months.

Treatment:

Drug: atherolive-drug

atherolive-placebo

Placebo Comparator group

Description:

The patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive-placebo) will be prescribed at a dose of 400 mg, once a day for 3 months.

Treatment:

Drug: Placebo Atherolive