ITMCTR2000003098招募中1 期
A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome
Affiliated Hospital of Shandong University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75(—)
- 性别
- All
入选标准
- •1. Aged between 18-75 years old;
- •2. Patients who meet the western diagnostic standard of grade 2 hypertension and the TCM syndrome differentiation standard of hyperactivity of liver Yang syndrome;
- •3. The patients with grade 2 essential hypertension and moderate risk are identified according to the blood pressure level and cardiovascular risk stratification of hypertension, whose blood pressure meet any one of the following three criteria:
- •(1) Systolic blood pressure 160-179mmHg and/or diastolic blood pressure 100-109 mmHg, no previous use of any antihypertensive drugs, no complications such as heart, brain and kidney;
- •(2) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy, maintaining the blood pressure at 160-179/100-109mmhg;
- •(3) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy and oral antihypertensive medication, maintaining the blood pressure at 160-179/100-109mmhg;
- •4. Patients whose course of hypertension must be more than 3 months;
- •5. Patients with informed consent and signing informed consent.
排除标准
- •1. With various secondary hypertension;
- •2. Patients Received other new drugs in the past 3 months;
- •3. Patients with moderate or severe diabetes or patients with myocardial infarction or cerebral apoplexy within half a year;
- •4. Pregnant or pregnant women and women in lactation;
- •5. Patients who are allergic to a variety of drugs or allergic constitution;
- •6. Patients with mental illness, alcoholism and/or psychoactive substance abuse and dependence;
- •7. With combining with the following organ damage or disease, angina pectoris, heart failure, transient brain, hypertensive encephalopathy, retinopathy (with or without apparent papillary edema), plasma creatinine concentration of 2.0 mg/dl or more renal function failure, liver failure, or aortic aneurysm, aortic dissecting aneurysm artery occlusive disease symptoms.
- •8. At present, patients who have taken valsartan 80mg/amlodipine 5mg and other ARB/CCB compound drugs, and whose blood pressure is still level 2 and above.
研究者
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