Chinese Medicine Treat for Hypertensive Renal Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients

Conditions
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Hypertension, Renal Injury

Intervention / Treatment
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* Drug: Losartan 100Mg Tab
* Drug: Qianyangyuyin 20g Granule
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: losartan & qianyangyuyin<br>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 100Mg Tab<br>* 100Mg Tab, qd, po, 6 months<br>* Other names: Cozaar;Drug: Qianyangyuyin 20g Granule<br>* 20g, Granule, bid, po, 6 months<br>|
| Placebo Comparator: Losartan & Placebo<br>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 100Mg Tab<br>* 100Mg Tab, qd, po, 6 months<br>* Other names: Cozaar;Drug: placebo<br>* Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months<br>* Other names: placebo(qianyangyuyin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albumin-to-creatinine ratio(UACR) | UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure level | 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. | 6 months | 
| Office blood pressure level 6/5000 Office blood pressure level | 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. | 6 months | 
| Traditional Chinese Medicine syndrome scores | 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). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, chronic kidney disease, traditional chinese medicine, early renal injury, albumin to creatinine ratio(UACR)