Chinese Medicine Treat for Hypertensive Renal Injury (CHAIR)

September 4, 2019 updated by: Zhu-Yuan Fang, Jiangsu Province Hospital of Traditional Chinese Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

520

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Losartan 100Mg Tab
100Mg Tab, qd, po, 6 months
Other Names:
  • Cozaar
Drug: Qianyangyuyin 20g Granule
20g, Granule, bid, po, 6 months
PLACEBO_COMPARATOR: 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.
Drug: Losartan 100Mg Tab
100Mg Tab, qd, po, 6 months
Other Names:
  • Cozaar
Drug: placebo
Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months
Other Names:
  • placebo(qianyangyuyin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
albumin-to-creatinine ratio(UACR)
Time Frame: 6 months
UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory blood pressure level
Time Frame: 6 months
ABPM was measured at baseline, 3 and 6 months. Both systolic and diastolic pressure was assessed. Hypertension was defined as mean ambulatory blood pressure of at least 130/80 mmHg.
6 months
Office blood pressure level 6/5000 Office blood pressure level
Time Frame: 6 months
Office blood pressure was measured at baseline and each month. Both systolic and diastolic pressure was assessed. Hypertension was defined as office blood pressure of at least 140/90 mmHg.
6 months
Traditional Chinese Medicine syndrome scores
Time Frame: 6 months
Self reported TCM syndrome scores at baseline and each month. Each main symptom is scored 0、2、4、6 (0 = no sympton; 6 = as heavy as can be), and each secondary symptom is scored 0、1、2、3(0=no symptom; 3= as heavy as can be).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Hospital of Traditional Chinese Medicine

Collaborators

Ministry of Science and Technology of the People´s Republic of China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Zhuyuan Fang, Jiangsu Province Hospital of Traditional Chinese Medicine
  • Study Director: Ming Liu, Jiangsu Province Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 10, 2019

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019NL-086-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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