Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- rate of blood pressure reduction
研究概览
简要总结
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).
- Or diabetes.
- Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease> 20% according to the Framingham scale (apart from hypertension and diabetes were included.
详细描述
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
- HbA1c (if the patient is diabetic).
- Inflammatory assessment: reactive protein C
Three populations will be randomized:
- The population of patients with hypertension.
- The population with diabetes.
- The population of patients with other risk factors with a Framingham> 20% In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age with:
- •Arterial hypertension (hypertension).
- •Or diabetes.
- •Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease> 20% according to the Framingham scale (apart from hypertension and diabetes.
- •Criteria exclusion:
- •. Exclusion criteria: None.
排除标准
- 未提供
研究组 & 干预措施
atherolive group
In each study population, the patient will be assigned to one of two treatments (atherolive or 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 (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.
干预措施: atherolive (Drug)
placebo group
In each study population, the patient will be assigned to one of two treatments (atherolive or 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 (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.
干预措施: atherolive (Drug)
结局指标
主要结局
rate of blood pressure reduction
时间窗: 90 days
blood pressure reduction on 24 hours holter
rate of fasting glycemia level reduction
时间窗: 90 days
morning glycemic cycle
次要结局
- rate of hospitalization for cardiovascular disease(90 days)
- rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile(90 days)
- rate of adverse effects(90 days)
研究者
Pr. Semir Nouira
Professor, Head of Emergency departement
University of Monastir