Olive Leaf Extracts in the Control of Hypertension
ConditionHypertension
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-95
SponsorUniversity of Monastir
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
. Exclusion criteria: None.
Trial design
Design model
Parallel
Treatments tested in this trial
atherolive-drug
DrugThe 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.
Placebo Atherolive
DrugThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: atherolive-drugActive comparator 1 intervention
Group B: atherolive-placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
rate of blood pressure reduction
blood pressure reduction on 24 hours holter
Time frame
90 daysSecondary outcomes
1
rate of lipid balance variation The secondary endpoint
variation in lipid reduction balance
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov