Clinical trial NCT02231138: Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
Official title: Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Abelmoschus manihot
Chronic Kidney Disease
proteinuria
efficacy
safety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
First posted: 2014-09-04
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time take.

Detailed description: The test has not been completed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)
* Blood pressure of ≤140/90mmHg
* Obtaining the signed informed consent from patients

Exclusion Criteria:

* Be allergic to Huangkui Capsule
* Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
* Lactation, pregnancy or plans pregnancy during the study period
* Participating in another clinical study in the same period

Primary outcomes:
measure: Change in 24-h proteinuria from baseline after treatment
timeFrame: Baseline(week 0), week 12, week 24
Secondary outcomes:
measure: change in the serum creatinine level from baseline after treatment
timeFrame: Baseline(week 0), week 12, week 24
measure: change in the estimated glomerular filtration rate (eGFR) from baseline after treatment
timeFrame: Baseline(week 0), week 12, week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Military General Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Dong Zhi Men Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: PLA Air Force General Hospital
state: Beijing
city: Beijing
country: China
facility: PLA Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: The First Affiliated Hospital of General Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: The Second Artillery General Hospital Of Chinese People's Liberation Army
state: Beijing
city: Chongqing
country: China
facility: Xin Qiao Hospital Of Third Military Medical University
state: Chongqing
city: Quanzhou
country: China
facility: Chinese People's Liberation Army No.180 Hospital
state: Fujian
city: Xiamen
country: China
facility: Chinese People's Liberation Army No.174 Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Guiyang
country: China
facility: Guizhou Province Hospital of Traditional Chinese Medicine
state: Guizhou
city: Guiyang
country: China
facility: The Affiliated Baiyun Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zun Yi Medical College
state: Guizhou
city: Haikou
country: China
facility: Hainan Medical College Affiliated Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial Nong Ken Hospital
state: Hainan
city: Chengde
country: China
facility: Affiliated Hospital of Cheng De Medical College
state: Hebei
city: Qinhuangdao
country: China
facility: First Hospital of Qinhuangdao
state: Hebei
city: Haerbin
country: China
facility: Heilongjiang Provincial Academy of Traditional Chinese Medicine
state: Heilongjiang
city: Haerbin
country: China
facility: The First Affiliated Hospital Of Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science And Technology
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Huanggang
country: China
facility: Huang Gang Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Hospital Of TCM
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Integrated TCM & Western Medicine Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiang Ya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiang Ya Hospital Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou Traditional Chinese Medicine Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Chinese People's Liberation Army No.94 Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital Of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital Of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: First Affiliated Hospital of Liaoning Medical University
state: Liaoning
city: Shenyang
country: China
facility: The General Hospital Of Shenyang Military Region
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Hui Autonomous Region's Hospital
state: Ningxia
city: Jinan
country: China
facility: Jinan General Hospital of PLA
state: Shandong
city: Jinan
country: China
facility: Qi Lu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Jining No.1 People's Hospital
state: Shandong
city: Taian
country: China
facility: Chinese People's Liberation Army No.88 Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yu Huang Ding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Chang Hai Hospital of the Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Hospital of Integrated Traditional And Western Medicine
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: The third People's Hospital of Chengdu
state: Sichuan
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital Of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Hospital of ITCWM, Nankai Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Hospital of Shi He Zi Medical University
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiangmei Chen, MD.& Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Li P, Xing CY, Zhao JY, He YN, Wang JQ, Wu XF, Liu ZS, Zhang AP, Lin HL, Ding XQ, Yin AP, Yuan FH, Fu P, Hao L, Miao LN, Xie RJ, Wang R, Zhou CH, Guan GJ, Hu Z, Lin S, Chang M, Zhang M, He LQ, Mei CL, Wang L, Chen X. Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial. Am J Kidney Dis. 2014 Jul;64(1):57-65. doi: 10.1053/j.ajkd.2014.01.431. Epub 2014 Mar 14.