Olive Leaf Extracts in the Control of Hypertension (Atherolive)

March 13, 2023 updated by: Pr. Semir Nouira, University of Monastir

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients over 18 years of age with:

Arterial hypertension (hypertension)

Exclusion Criteria:

  • . Exclusion criteria: None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: atherolive-drug
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
placebo
Other Names:
  • atherolive-placebo
Placebo Comparator: atherolive-placebo
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
placebo
Other Names:
  • atherolive-placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of blood pressure reduction
Time Frame: 90 days
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
Time Frame: 90 days
variation in lipid reduction balance
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2023

Primary Completion (Anticipated)

November 22, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATHEROLIVE-HTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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