ITMCTR2100004710尚未招募4 期
A multi-center, randomized, double-blind, double-simulated, and positive-drug parallel-controlled clinical study to evaluate the effectiveness and safety of Quanduzhong capsule in treating essential hypertension&
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
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
- 性别
- All
入选标准
- •(1)diagnose with essential hypertension;
- •(2)stage 1-2 hypertension(clinical blood pressure:mean sitting systolic blood pressure 140-179mmHg and (or) mean sitting diastolic blood pressure 90-109mmHg)without severe target organ damages;
- •(3)diagnose with nephrasthenia syndrome;
- •(4)aged between 18-70 years old, male or female;
- •(5)the subject are allowed to have the following conditions:
- •a.the subject has not previously been diagnosed with hypertension or has not received antihypertensive treatment;
- •b.the subject has been diagnosed with hypertension in the past, but has not taken antihypertensive drugs regularly, and has not taken any antihypertensive drugs within 2 weeks before participating this tial;
- •(6)subjects are volunteered to signed the informed consent.
排除标准
- •(1)those are diagnosed with chronic congestive heart failure (NYHA grade III and IV) or acute coronary syndrome, transient ischemic attack, myocardial infarction, percutaneous coronary intervention, stroke in the past 6 months before participating this trial;
- •(2)those with severe heart disease (such as aortic aneurysm or aortic dissecting aneurysm, unstable angina, cardiogenic shock, arrhythmia requiring treatment, valvular disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc.) in the past or at present;
- •(3)those who is known or suspected to has secondary hypertension, hypertensive emergency or sub-emergency, hypertensive crisis
- •(4)those who cannot tolerate the 2-week run-in period
- •(5)combined with other primary serious liver, kidney or blood system diseases or malignant tumorsthose with ALT and AST exceeding 1.5 times the upper limit of normal value, and Cr exceeding the upper limit of normal value
- •(6)those with poorly controlled diabetes, those with fasting blood glucose> 10.0 mmol/L
- •(7)those with gastrointestinal surgery that may significantly change the absorption, distribution, metabolism and excretion of drugs(such as gastrectomy, gastrointestinal anastomosis or bowel resection, gastric bypass, gastrointestinal band surgery etc.)
- •(8)woman during pregnancy or lactation or those who have a birth plan during this trial or 3 months after the end of this trial
- •(9)excessive smoking (>10 cigarettes/day) and/or alcoholism (drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits, or about 100 ml of wine);
- •(10)those with mental disorders or those who is known or suspected to has a history of drug abuse;
- •(11)tose whose blood pressure is affected due to occupational factors and other reasons such as working at heights, motor vehicle driving with dangerous mechanical operations, working hours are night shifts(11 pm [23:00] to 7 am [07:00], only applicable to those with ambulatory blood pressure monitoring)
- •(12)those who participated in other clinical trials in the past 3 months
- •(13)those who are inappropriate to participate in this research.
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