Olive Leaf Extracts in the Control of Hypertension

NCT ID: NCT05636826

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2025-12-30

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 .

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

atherolive-drug

Intervention Type 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.

atherolive-placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo Atherolive

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients over 18 years of age with:

Arterial hypertension (hypertension)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

clinical proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Fattouma Bourguiba Monastir

Monastir, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Nouira semir, Pr

Role: CONTACT

73106046 ext. 216

Bel Hadj Ali khaoula, MD

Role: CONTACT

73106046 ext. 216

Facility Contacts

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Semir Nouira, Professor

Role: primary

0021673106046

Other Identifiers

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ATHEROLIVE-HTA

Identifier Type: -

Identifier Source: org_study_id

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