Olive Leaf Extracts in the Control of Hypertension

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: atherolive-drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years of age with: Arterial hypertension (hypertension) Exclusion Criteria: . Exclusion criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atherolive-drug<br>In each study population, 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. | Drug: atherolive-drug<br>* placebo<br>* Other names: atherolive-placebo;|
| Placebo Comparator: atherolive-placebo<br>In each study population, the patient will be assigned to one of two treatments (placebo ) 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. | Drug: atherolive-drug<br>* placebo<br>* Other names: atherolive-placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of blood pressure reduction | blood pressure reduction on 24 hours holter | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of lipid balance variation The secondary endpoint | variation in lipid reduction balance | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension