NCT04078711

Chinese Medicine Treat for Hypertensive Renal Injury

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Renal Injury

Interventions

Type	Name	Description
DRUG	Losartan 100Mg Tab	100Mg Tab, qd, po, 6 months
DRUG	Qianyangyuyin 20g Granule	20g, Granule, bid, po, 6 months
DRUG	placebo	Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-06-30
• Completion: 2021-12-30
• First posted: 2019-09-06
• Last updated: 2019-09-06