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Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients
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.
Age
35 - 55 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 10, 2019
Primary Completion Date
June 30, 2021
Completion Date
December 30, 2021
Last Updated
September 6, 2019
520
ESTIMATED participants
Losartan 100Mg Tab
DRUG
Qianyangyuyin 20g Granule
DRUG
placebo
DRUG
Lead Sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborators
NCT02417740
NCT07073820
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07480265