NCT05636826

Olive Leaf Extracts in the Control of Hypertension

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Hypertension

Interventions

Type	Name	Description
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 (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months.
DRUG	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. Placebo will be prescribed at a dose of 400 mg, once a day for 3 months.

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-11-22
• Completion: 2025-12-30
• First posted: 2022-12-05
• Last updated: 2024-11-08

Locations

1 site across 1 country: Tunisia