Clinical trial NCT04078711: Chinese Medicine Treat for Hypertensive Renal Injury
Official title: Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hypertension
Renal Injury
Keywords: hypertension
chronic kidney disease
traditional chinese medicine
early renal injury
albumin to creatinine ratio(UACR)
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First posted: 2019-09-06
Enrollment: 520
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: albumin-to-creatinine ratio(UACR)
timeFrame: 6 months
Secondary outcomes:
measure: Ambulatory blood pressure level
timeFrame: 6 months
measure: Office blood pressure level 6/5000 Office blood pressure level
timeFrame: 6 months
measure: Traditional Chinese Medicine syndrome scores
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Zhuyuan Fang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Ming Liu
role: STUDY_DIRECTOR
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