Antihypertensive Effects of Rosmarinus Officinalis L. Infusion Supplements in Male Patients With Mild Hypertension : A Randomized Double-Blind Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Measurement of ambulatory blood pressure
研究概览
简要总结
This study assessed the antihypertensive effect of rosemary tea through a placebo-controlled clinical study, angiotensin-converting enzyme (ACE) inhibition analysis, and in silico evaluation of interactions between rosemary bioactive compounds and the AT1R (Angiotensin II Type 1 Receptor).
A randomized, double-blind, placebo-controlled trial was conducted in 54 male patients with mild hypertension. Participants were assigned to receive either rosemary infusion (n = 27) or placebo (n = 23) for 45 days. Ambulatory blood pressure monitoring wass used to evaluate blood pressure parameters. Serum ACE activity was measured at baseline and after the intervention using FAPGG hydrolysis. Molecular docking simulations were performed using the Dock 4.2 software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 28-65 years
- •Mild hypertension, defined as systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg, according to ESC/ESH 2018 guidelines
- •No history of chronic diseases
- •Not currently taking antihypertensive medications, other drugs, or dietary supplements
- •Body mass index (BMI) within the screening range at recruitment
- •Provided written informed consent
排除标准
- •Secondary hypertension
- •History of cardiovascular disease, diabetes mellitus, renal failure, autoimmune disease, or major gastrointestinal disorders
- •Current use of medications affecting blood pressure
- •Extreme body mass index (BMI) values
- •Significant dietary changes or irregular physical activity in the previous six months
- •Alcohol consumption or use of illicit drugs
- •Inability or unwillingness to maintain usual diet and lifestyle during the study
研究组 & 干预措施
bras 2: placebo
Infusion with color and taste similar to rosemary, without active extract
Administered orally, 1 cup (100 mL) per day
Duration: 6 weeks
干预措施: Placebo (Dietary Supplement)
Bras 1 rosemary infusion
Infusion prepared from 2g of rosemary leaves. Administered orally, 1 cup (100 mL) per day.
Duration: 6 weeks.
干预措施: Rosemary extract infusion (Dietary Supplement)
结局指标
主要结局
Measurement of ambulatory blood pressure
时间窗: 6 weeks
ABPM was utilized to improve the accuracy of the clinical trial while minimizing the required number of participants. Blood pressure mea- surements were taken at the brachial artery using a Holter SunTech Medical Oscar 2 device (INC S07Air Port Blvd, Suite 117, Morrisville, NC, USA) to monitor BP over a 24-hour period. The device was set to record BP every 30 min during the day and every hour at night. The cuff was placed on the non-dominant arm, enabling the participants to carry on with their normal activities. They were instructed to stay still during cuff inflation. The sleep and wake times for programming the Holter device were established based on a question asked to the subjects during their visit. These measurements were recorded on Day 0 (D0) and Day 45 (D45) to assess the impact of the rosemary infusion on blood pressure. We assessed the following blood pressure parameters: 24-h, daytime, and nighttime SBP and DBP, mean blood pressure (MBP), heart rate (HR), and nocturnal d
次要结局
- Determination of serm angiotensin-converting enzyme activity(6 weeks)
- Biochemical Analysis and Assessment(6 weeks)
- Evaluation Perceived Benefits of Rosemary infusion(6 weeks)
研究者
awatef Sassi
PHD Assistant Professor at the Private Higher Institute of Nursing Sciences
Faculty of Medicine, Sousse