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Olive Leaf Extracts in the Control of Hypertension (Atherolive)

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
atherolive-drug
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    atherolive-drug

    atherolive-placebo

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    rate of blood pressure reduction
    blood pressure reduction on 24 hours holter

    Secondary Outcome Measures

    rate of lipid balance variation The secondary endpoint
    variation in lipid reduction balance

    Full Information

    First Posted
    November 23, 2022
    Last Updated
    March 13, 2023
    Sponsor
    University of Monastir
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05636826
    Brief Title
    Olive Leaf Extracts in the Control of Hypertension
    Acronym
    Atherolive
    Official Title
    Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2023 (Anticipated)
    Primary Completion Date
    November 22, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Monastir

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    atherolive-drug
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    atherolive-placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    atherolive-drug
    Other Intervention Name(s)
    atherolive-placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    rate of blood pressure reduction
    Description
    blood pressure reduction on 24 hours holter
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    rate of lipid balance variation The secondary endpoint
    Description
    variation in lipid reduction balance
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients over 18 years of age with: Arterial hypertension (hypertension) Exclusion Criteria: . Exclusion criteria: None.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nouira semir, Pr
    Phone
    73106046
    Ext
    216
    Email
    semir.nouira@rns.tn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bel Hadj Ali khaoula, MD
    Phone
    73106046
    Ext
    216
    Email
    belhadjalikhaoula@yahoo.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Olive Leaf Extracts in the Control of Hypertension

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