Chinese Medicine Treat for Hypertensive Renal Injury

NCT ID: NCT04078711

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-12-30

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.

Conditions

Hypertension; Renal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

losartan & qianyangyuyin

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.

Group Type: EXPERIMENTAL

Losartan 100Mg Tab

Intervention Type: DRUG

100Mg Tab, qd, po, 6 months

Qianyangyuyin 20g Granule

Intervention Type: DRUG

20g, Granule, bid, po, 6 months

Losartan & 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.

Group Type: PLACEBO_COMPARATOR

Losartan 100Mg Tab

Intervention Type: DRUG

100Mg Tab, qd, po, 6 months

placebo

Intervention Type: DRUG

Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Interventions

Losartan 100Mg Tab

100Mg Tab, qd, po, 6 months

Intervention Type: DRUG

Qianyangyuyin 20g Granule

20g, Granule, bid, po, 6 months

Intervention Type: DRUG

placebo

Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Intervention Type: DRUG

Other Intervention Names

Cozaar; placebo(qianyangyuyin)

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zhu-Yuan Fang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhuyuan Fang

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Hospital of Traditional Chinese Medicine

Ming Liu

Role: STUDY_DIRECTOR

Jiangsu Province Hospital of Traditional Chinese Medicine

Central Contacts

Ming Liu

Role: CONTACT

liumingxinghua@163.com

13815885859

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019NL-086-02

Identifier Type: -

Identifier Source: org_study_id