Chinese Medicine Treat for Hypertensive Renal Injury

Phase 2

• Conditions: Renal Injury; Hypertension
• Interventions: Drug: Losartan 100Mg Tab; Drug: Qianyangyuyin 20g Granule; Drug: placebo

• Registration Number: NCT04078711
• Lead Sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Study Start: 2019-09-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
losartan & qianyangyuyin	Qianyangyuyin 20g Granule	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 & Placebo	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.
Losartan & Placebo	Losartan 100Mg Tab	Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months.
losartan & qianyangyuyin	Losartan 100Mg Tab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ambulatory blood pressure level	6 months	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 level 6/5000 Office blood pressure level	6 months	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.
Traditional Chinese Medicine syndrome scores	6 months	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).