Limits...
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 W, Zhang L, Zou C, Li C, Wu Y, Su G, Guo X, Wu Y, Lu F, Lin Q, Wang L, Bao K, Xu P, Zhao D, Peng Y, Liang H, Lu Z, Gao Y, Jie X, Zhang L, Wen Z, Liu X - BMC Complement Altern Med (2015)

Bottom Line: Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.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.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@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 .

No MeSH data available.


Related in: MedlinePlus

Ultra-performance liquid chromatography-mass spectrometry pattern of Bupi Yishen formula
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4562196&req=5

Fig2: Ultra-performance liquid chromatography-mass spectrometry pattern of Bupi Yishen formula

Mentions: The chemical content of BYF was assessed by Ultra-performance liquid chromatography-mass spectrometry (LC-MS), and the five major chemical components were found to be Salvianolic acid B, Calycosin, Cuscutic acid C, glycerin trioleate and Astragaloside I (Figs. 2 and 3). In 2014, the BYF formula and the methods of producing it were approved and patented as a treatment for CKD by the Chinese State Intellectual Property Office (NO. 2012100298628).


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 W, Zhang L, Zou C, Li C, Wu Y, Su G, Guo X, Wu Y, Lu F, Lin Q, Wang L, Bao K, Xu P, Zhao D, Peng Y, Liang H, Lu Z, Gao Y, Jie X, Zhang L, Wen Z, Liu X - BMC Complement Altern Med (2015)

Ultra-performance liquid chromatography-mass spectrometry pattern of Bupi Yishen formula
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4562196&req=5

Fig2: Ultra-performance liquid chromatography-mass spectrometry pattern of Bupi Yishen formula
Mentions: The chemical content of BYF was assessed by Ultra-performance liquid chromatography-mass spectrometry (LC-MS), and the five major chemical components were found to be Salvianolic acid B, Calycosin, Cuscutic acid C, glycerin trioleate and Astragaloside I (Figs. 2 and 3). In 2014, the BYF formula and the methods of producing it were approved and patented as a treatment for CKD by the Chinese State Intellectual Property Office (NO. 2012100298628).

Bottom Line: Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.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.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@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 .

No MeSH data available.


Related in: MedlinePlus