| Trial ID: | L3888 |
| Source ID: | NCT05297110
|
| Associated Drug: |
Atherolive
|
| Title: |
Olive Leaf Extracts in the Control of Cardiovascular Risk
|
| Acronym: |
Atherolive
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Hypertension
|
| Interventions: |
DRUG: atherolive
|
| Outcome Measures: |
Primary: rate of blood pressure reduction, blood pressure reduction on 24 hours holter, 90 days|rate of fasting glycemia level reduction, morning glycemic cycle, 90 days | Secondary: rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile, variation in lipid balance, 90 days|rate of hospitalization for cardiovascular disease, rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke, 90 days|rate of adverse effects, number of adeverse evnets reported, 90 days
|
| Sponsor/Collaborators: |
Sponsor: University of Monastir
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
1000
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
|
| Start Date: |
2021-08-01
|
| Completion Date: |
2023-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-04
|
| Locations: |
Fattouma Bourguiba Monastir University Hospital Center, Monastir, 5000, Tunisia
|
| URL: |
https://clinicaltrials.gov/show/NCT05297110
|
