Chinese Medicine Treat for Hypertensive Renal Injury (CHAIR)

Ministry of Science and Technology of the People´s Republic of China, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

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.

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.

hypertension, chronic kidney disease, traditional chinese medicine, early renal injury, albumin to creatinine ratio(UACR)

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.

Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months.

UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.

ABPM was measured at baseline, 3 and 6 months. Both systolic and diastolic pressure was assessed. Hypertension was defined as mean ambulatory blood pressure of at least 130/80 mmHg.

Office blood pressure was measured at baseline and each month. Both systolic and diastolic pressure was assessed. Hypertension was defined as office blood pressure of at least 140/90 mmHg.

Self reported TCM syndrome scores at baseline and each month. Each main symptom is scored 0、2、4、6 (0 = no sympton; 6 = as heavy as can be), and each secondary symptom is scored 0、1、2、3(0=no symptom; 3= as heavy as can be).

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

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