Chinese Medicine Treat for Hypertensive Renal Injury
关键词
抽象
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.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 09/01/2019 |
| 提交的预估入学人数: | 09/01/2019 |
| 首次发布: | 09/05/2019 |
| 上次提交的更新: | 09/03/2019 |
| 最近更新发布: | 09/05/2019 |
| 实际学习开始日期: | 09/09/2019 |
| 预计主要完成日期: | 06/29/2021 |
| 预计完成日期: | 12/29/2021 |
状况或疾病
干预/治疗
Drug: Losartan 100Mg Tab
Drug: losartan & qianyangyuyin
Drug: Losartan & Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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. | Drug: losartan & qianyangyuyin 20g, Granule, bid, po, 6 months |
| Placebo Comparator: 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. | Drug: Losartan & Placebo Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months |
资格标准
| 有资格学习的年龄 | 35 Years 至 35 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. albumin-to-creatinine ratio(UACR) [6 months]
次要成果指标
1. Ambulatory blood pressure level [6 months]
2. Office blood pressure level 6/5000 Office blood pressure level [6 months]
3. Traditional Chinese Medicine syndrome scores [6 months]
