Chinese Medicine Treat for Hypertensive Renal Injury (CHAIR)

Jiangsu Province Hospital of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hypertension; Renal Injury

Treatments: Drug: placebo; Drug: Qianyangyuyin 20g Granule; Drug: Losartan 100Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT04078711

2019NL-086-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 2 patient groups, including a placebo group

losartan & qianyangyuyin

Experimental group

Description:

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.

Treatment:

Drug: Losartan 100Mg Tab

Drug: Qianyangyuyin 20g Granule

Losartan & Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Losartan 100Mg Tab

Drug: placebo