Olive Leaf Extracts in the Control of Hypertension

Phase 2

Recruiting

• Conditions: Hypertension
• Interventions: Drug: atherolive-drug; Drug: Placebo Atherolive

• Registration Number: NCT05636826
• Lead Sponsor: University of Monastir

Brief Summary

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).

Detailed 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 .

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Start: 2023-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-08
• Primary Completion: 2024-11-22
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients over 18 years of age with:

Arterial hypertension (hypertension)

Exclusion Criteria

• . Exclusion criteria: None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atherolive-drug	atherolive-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 (atherolive) will be prescribed at a dose of 400 mg, once a day for 3 months.
atherolive-placebo	Placebo Atherolive	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.

Primary Outcome Measures

Name	Time	Method
rate of blood pressure reduction	90 days	blood pressure reduction on 24 hours holter

Secondary Outcome Measures

Name	Time	Method
rate of lipid balance variation The secondary endpoint	90 days	variation in lipid reduction balance

Trial Locations

Locations (1)

University Hospital Fattouma Bourguiba Monastir; 🇹🇳 Monastir, Tunisia