Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02231138
• Other study ID #: S2014-040-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 30, 2014
• Last updated: May 31, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and TechnologyChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The test has not been completed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Abelmoschus manihot (AM)
Abelmoschus manihot (AM): Huanghui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Military General Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Dong Zhi Men Hospital of Beijing University of Chinese Medicine	Beijing	Beijing
China	PLA Air Force General Hospital	Beijing	Beijing
China	PLA Navy General Hospital	Beijing	Beijing
China	The First Affiliated Hospital of General Hospital of PLA	Beijing	Beijing
China	The Second Artillery General Hospital Of Chinese People's Liberation Army	Beijing	Beijing
China	The Second Hospital Of Jilin University	Changchun	Jilin
China	The Second Xiang Ya Hospital of Central South University	Changsha	Hunan
China	Xiang Ya Hospital Central South University	Changsha	Hunan
China	Affiliated Hospital of Cheng De Medical College	Chengde	Hebei
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	The third People's Hospital of Chengdu	Chengdu	Sichuan
China	Xin Qiao Hospital Of Third Military Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second Hospital Of Dalian Medical University	Dalian	Liaoning
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou
China	Guizhou Province Hospital of Traditional Chinese Medicine	Guiyang	Guizhou
China	The Affiliated Baiyun Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Heilongjiang Provincial Academy of Traditional Chinese Medicine	Haerbin	Heilongjiang
China	The First Affiliated Hospital Of Heilongjiang University of Chinese Medicine	Haerbin	Heilongjiang
China	Hainan Medical College Affiliated Hospital	Haikou	Hainan
China	Hainan Provincial Nong Ken Hospital	Haikou	Hainan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Huang Gang Central Hospital	Huanggang	Hubei
China	Jinan General Hospital of PLA	Jinan	Shandong
China	Qi Lu Hospital of Shandong University	Jinan	Shandong
China	Jining No.1 People's Hospital	Jining	Shandong
China	First Affiliated Hospital of Liaoning Medical University	Jinzhou	Liaoning
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Second Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science And Technology	Luoyang	Henan
China	Chinese People's Liberation Army No.94 Hospital	Nanchang	Jiangxi
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi University of Chinese Medicine	Nanning	Guangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Chinese People's Liberation Army No.180 Hospital	Quanzhou	Fujian
China	Chang Hai Hospital of the Second Military Medical University	Shanghai	Shanghai
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	The General Hospital Of Shenyang Military Region	Shenyang	Liaoning
China	The First Hospital of Shi He Zi Medical University	Shihezi	Xinjiang
China	Chinese People's Liberation Army No.88 Hospital	Taian	Shandong
China	Shanxi Hospital of Integrated Traditional And Western Medicine	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu
China	Taizhou Traditional Chinese Medicine Hospital	Taizhou	Jiangsu
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	The Second Hospital Of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Hospital of ITCWM, Nankai Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Hubei Provincial Hospital Of TCM	Wuhan	Hubei
China	Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology	Wuhan	Hubei
China	Wuhan Integrated TCM & Western Medicine Hospital	Wuhan	Hubei
China	Chinese People's Liberation Army No.174 Hospital	Xiamen	Fujian
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Yantai Yu Huang Ding Hospital	Yantai	Shandong
China	Ningxia Hui Autonomous Region's Hospital	Yinchuan	Ningxia
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zun Yi Medical College	Zunyi	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Jiangsu Suzhong Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-h proteinuria from baseline after treatment		Baseline(week 0), week 12, week 24	No
Secondary	change in the serum creatinine level from baseline after treatment		Baseline(week 0), week 12, week 24	No
Secondary	change in the estimated glomerular filtration rate (eGFR) from baseline after treatment		Baseline(week 0), week 12, week 24	No