Olive Leaf Extracts in the Control of Hypertension
Atherolive
Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension
1 other identifier
interventional
500
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hypertension
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 8, 2024
November 1, 2024
11 months
November 23, 2022
November 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of blood pressure reduction
blood pressure reduction on 24 hours holter
90 days
Secondary Outcomes (1)
rate of lipid balance variation The secondary endpoint
90 days
Study Arms (2)
atherolive-drug
ACTIVE COMPARATORThe 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.
atherolive-placebo
PLACEBO COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- patients over 18 years of age with:
- Arterial hypertension (hypertension)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Fattouma Bourguiba Monastir
Monastir, Tunisia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical proffesor
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 5, 2022
Study Start
December 30, 2023
Primary Completion
November 22, 2024
Study Completion
December 30, 2025
Last Updated
November 8, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share