IRCT20140519017756N34招募中2 期
A clinical trial comparing the effects of placebo and the Iranian traditional medicinal product of mao’ljabn or cheese-water on primary hypertension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- All
入选标准
- •Being in stage 1 hypertension (i.e., systolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg based on the new definition of the Joint National Committee-8
- •Being treated with blood pressure medication (one to a maximum of three drugs based on the protocol), but the patient’s blood pressure is uncontrolled and still in stage 1 hypertension
- •A minimum of one month passed from the onset of drug consumption
- •Body mass index below 30
- •Age between 18 and 80 years
排除标准
- •Stage 2 or above according to hypertension classification of the Joint National Committee-VIII
- •Blood pressure greater than or equal to 110/180 mmHg
- •History of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing's syndrome)
- •Endocrine disruption symptoms such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents from the 6 months prior to the study onset
- •The presence of any type of cardiac arrhythmia (such as second- or third-degree blocks)
- •Symptomatic heart valve disease (except for mitral valve prolapse)
- •Type 1 and type 2 diabetic patients
- •Clinically significant renal and hepatic dysfunction, i.e., creatinine greater than 1.5 times the maximum normal and alanine aminotransferase more than 3 times the normal maximum
- •Number of platelets less than -100,000 or partial thromboplastin time more than 1.5
- •Pregnancy or breastfeeding intentions
- •Known or potential allergy to the tested product
- •Participation in any other clinical trials at the same time or within the last 30 days
- •History of malignancy treated or untreated in the last 5 years
- •Chronic oral or intravenous treatment with corticosteroids
- •Serum potassium greater than 5.2 or less than 3.5 milliequivalents in the first visit
- •Consuming contraceptive pills or psychiatric drugs
- •History of drug abuse, alcohol abuse, etc.
- •Any disruption (medical or surgical) that can interfere with the study according to the investigator or another serious illness
- •The patient's inappropriate cooperation in the project or compromising the patient’s safety or the incidence of any potential adverse effect by the drug
- •Childbirth during the project
研究者
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