Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Office blood pressure
研究概览
简要总结
Hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. It is the leading risk factor of cardiovascular disease.
Berberine (BBR) hydrochloride is an isoquinoline alkaloid (chemical formula: C20H18NO4) extracted from traditional Chinese herb Coptis chinensis. It has been widely used to treat diarrhea and enteritis for hundreds of years in China. BBR has extremely high clinical application value. It is an over-the-counter drug with low price, good safety and few adverse reactions in China.
We found that Berberine (BBR) hydrochloride tablets have a hypotensive effect in clinical practice. However, there are few clinical studies on the treatment of hypertensive patients with BBR tablets. In addition, the clinical dosage of BBR tablets is not uniform, and its molecular mechanism is still unclear.
In order to further evaluate the clinical efficacy of BBR in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population.
After signed the informed consent, the subjects are assigned to the lifestyle intervention group (CON) and berberine hydrochloride group (BBR). The berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . We will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
- •18 to 75 years old
- •No drugs or dietary supplements that affect blood pressure and vascular endothelial function have been used in the past 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants
- •Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of the study, characters of the disease, drug effects, methods of related examinations, and potential risk/benefits of the study
排除标准
- •Individuals with secondary blood pressure rise factors
- •Individuals who are hypersensitive or intolerant to the drugs
- •Individuals presenting severe constipation
- •Individuals with severe heart disease, abnormal liver and kidney function, acute and chronic infections, autoimmune diseases and patients with any history of cancer
- •Individuals with mental diseases who are not able to cooperate
- •Pregnant women, women during breast-feeding period, or women with expect pregnancy
- •Individuals with hemolytic anemia and glucose-6 phosphate dehydrogenase deficiency
研究组 & 干预措施
berberine hydrochloride group
the berberine hydrochloride group (BBR) take berberine hydrochloride tablets
干预措施: berberine hydrochloride (Drug)
lifestyle intervention group
Lifestyle intervention group (CON) refers to healthy lifestyle education
干预措施: lifestyle intervention group (Behavioral)
结局指标
主要结局
Office blood pressure
时间窗: 3 months
BP measurement was in accordance with the method recommended by clinical guidelines. After rest for at least 5 minutes, subjects were examined while seated in a quiet, temperature-controlled room, with the feet on the floor and arm supported at heart level. BP was measured using an automated device at least 2 measurements spaced 2 minutes apart, and additional measurements if the first 2 are quite different. Average BP readings were recorded.
brachial-ankle pulse wave velocity (baPWV)
时间窗: 3 months
baPWV was measured by using an automatic device as reported previously and was expressed as centimeters per second (cm/sec). The measurement of baPWV is generally accepted as the simplest, robust, and reproducible method to represent arterial stiffness.
次要结局
- 24-hour ambulatory blood pressure monitoring (ABPM)(3 months)
- brachial arterial flow-mediated dilation (FMD)(3 months)
研究者
Jun Tao
Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor
First Affiliated Hospital, Sun Yat-Sen University