Rationale and design of the Helping Ease Renal failure with Bupi Yishen compared with the Angiotensin II Antagonist Losartan (HERBAAL) trial: a randomized controlled trial in non-diabetes stage 4 chronic kidney disease.
BACKGROUND
Chronic kidney disease (CKD) is a global public health problem. Currently, as for advanced CKD populations, medication options limited in angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB), which were partially effective. A Chinese herbal compound, Bupi Yishen formula, has showed renal protective potential in experiments and retrospective studies. This study will evaluate the efficacy and safety of Bupi Yishen formula (BYF) in patients with CKD stage 4.


METHODS
In this double blind, double dummy, randomized controlled trial (RCT), there will be 554 non-diabetes stage 4 CKD patients from 16 hospitals included and randomized into two groups: Chinese medicine (CM) group or losartan group. All patients will receive basic conventional therapy. Patients in CM group will be treated with BYF daily while patients in control group will receive losartan 100 mg daily for one year. The primary outcome is the change in estimated glomerular filtration rate (eGFR) over 12 months. Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.


CONCLUSIONS
This study will be the first multi-center, double blind RCT to assess whether BYF, compared with losartan, will have beneficial effects on eGFR for non-diabetes stage 4 CKD patients. The results will help to provide evidence-based recommendations for clinicians.


BACKGROUND
Chinese Clinical Trial Registry Number: ChiCTR-TRC-10001518 .
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@126.com.
Wei
W
Mao
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. zlbread@126.com.
Lei
L
Zhang
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. doctorzc541888@126.com.
Chuan
C
Zou
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. mistlandy@163.com.
Chuang
C
Li
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wuyifan007@163.com.
Yifan
Y
Wu
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. benedictcm@126.com.
Guobin
G
Su
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. guoxinfeng@139.com.
Xinfeng
X
Guo
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wuyuchi047@163.com.
Yuchi
Y
Wu
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. lfh0307@126.com.
Fuhua
F
Lu
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. linqizhan656635@163.com.
Qizhan
Q
Lin
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wanglixin1210@163.com.
Lixin
L
Wang
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. baokun@aliyun.com.
Kun
K
Bao
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. dr_xupeng@163.com.
Peng
P
Xu
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. greatdasin@163.com.
Daixin
D
Zhao
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. pengyu@medmail.com.cn.
Yu
Y
Peng
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 1273885601@qq.com.
Hui
H
Liang
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. lu_zhaoyu@163.com.
Zhaoyu
Z
Lu
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 18650286899@163.com.
Yanxiang
Y
Gao
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 5231200@qq.com.
Xina
X
Jie
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 124366453@qq.com.
La
L
Zhang
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wenzh@gzucm.edu.cn.|National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. wenzh@gzucm.edu.cn.
Zehuai
Z
Wen
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. xushengliu801@126.com.
Xusheng
X
Liu
D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007668:Kidney / Q000503:physiopathology; D019808:Losartan / Q000009:adverse effects / Q000627:therapeutic use; D051437:Renal Insufficiency / Q000188:drug therapy*
D047228:Angiotensin II Type 1 Receptor Blockers; D004365:Drugs, Chinese Herbal; D019808:Losartan