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BMC Complement Altern Med. 2015 Sep 8;15:316. doi: 10.1186/s12906-015-0830-1.

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.

Mao W1, Zhang L2, Zou C3, Li C4, Wu Y5, Su G6, Guo X7, Wu Y8, Lu F9, Lin Q10, Wang L11, Bao K12, Xu P13, Zhao D14, Peng Y15, Liang H16, Lu Z17, Gao Y18, Jie X19, Zhang L20, Wen Z21,22, Liu X23.

Author information

1
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@126.com.
2
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. zlbread@126.com.
3
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. doctorzc541888@126.com.
4
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. mistlandy@163.com.
5
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wuyifan007@163.com.
6
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. benedictcm@126.com.
7
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. guoxinfeng@139.com.
8
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wuyuchi047@163.com.
9
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. lfh0307@126.com.
10
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. linqizhan656635@163.com.
11
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wanglixin1210@163.com.
12
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. baokun@aliyun.com.
13
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. dr_xupeng@163.com.
14
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. greatdasin@163.com.
15
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. pengyu@medmail.com.cn.
16
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 1273885601@qq.com.
17
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. lu_zhaoyu@163.com.
18
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 18650286899@163.com.
19
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 5231200@qq.com.
20
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 124366453@qq.com.
21
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. wenzh@gzucm.edu.cn.
22
National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. wenzh@gzucm.edu.cn.
23
Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. xushengliu801@126.com.

Abstract

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.

DESIGN:

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.

DISCUSSION:

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.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry Number: ChiCTR-TRC-10001518 .

PMID:
26351087
PMCID:
PMC4562196
DOI:
10.1186/s12906-015-0830-1
[Indexed for MEDLINE]
Free PMC Article

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