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Completed

NCT Number: NCT05636826

Olive Leaf Extracts in the Control of Hypertension

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).

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Fattouma Bourguiba Monastir

Monastir, Tunisia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients over 18 years of age with:

Arterial hypertension (hypertension)

Exclusion criteria

  • . Exclusion criteria: None.

Treatment and study plan

atherolive-drug

Drug

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 (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months.

Placebo Atherolive

Drug

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. Placebo will be prescribed at a dose of 400 mg, once a day for 3 months.

Primary outcomes

  1. rate of blood pressure reduction

    Time frame: 90 days

    blood pressure reduction on 24 hours holter

Secondary outcomes

  1. rate of lipid balance variation The secondary endpoint

    Time frame: 90 days

    variation in lipid reduction balance

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension

Acronym: Atherolive

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 5, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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