Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 520
- 主要终点
- albumin-to-creatinine ratio(UACR)
研究概览
简要总结
This study evaluates whether the traditional chinese medicine (Qianyangyuyin formula) could prevent and treat early renal injury in patients with hypertension and microalbuminuria (defined as a urinary albumin to creatinine ratio between 30 and 300 mg/g) based on standard antihypertensive treatment.
详细描述
Hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. The higher the blood pressure level, the higher the risk of these diseases. Antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. A multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of Chinese medicine (Qianyanguuyin formula) in improving urinary albumin to creatinine ratio (ACR), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). Patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (ACR of 30-300 mg/g) and eGFR of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome. It's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has primary hypertension(grades 2-3)
- •Subject has microalbuminuria [defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min∙1.73m2)]
- •Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome
- •Subject voluntarily participates in the trial and signs informed consent
排除标准
- •Subject has secondary hypertension
- •Subject with pregnancy or lactating
- •Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia
- •Subject's liver function (AST or ALT) is 2 times greater than normal value
- •Subject has history of mental illness
- •Subject currently participates in other drug clinical trials
研究组 & 干预措施
losartan & qianyangyuyin
Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Chinese Medicine (Qianyangyuyin granule) 20g by mouth, bid for 6 months.
干预措施: Losartan 100Mg Tab (Drug)
losartan & qianyangyuyin
Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Chinese Medicine (Qianyangyuyin granule) 20g by mouth, bid for 6 months.
干预措施: Qianyangyuyin 20g Granule (Drug)
Losartan & Placebo
Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months.
干预措施: Losartan 100Mg Tab (Drug)
Losartan & Placebo
Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months.
干预措施: placebo (Drug)
结局指标
主要结局
albumin-to-creatinine ratio(UACR)
时间窗: 6 months
UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.
次要结局
- Ambulatory blood pressure level(6 months)
- Office blood pressure level 6/5000 Office blood pressure level(6 months)
- Traditional Chinese Medicine syndrome scores(6 months)
研究者
Zhu-Yuan Fang
Professor
Jiangsu Province Hospital of Traditional Chinese Medicine