Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Abelmoschus manihot (AM)

Detailed Description

The test has not been completed.

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Second Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100000
      • Chinese PLA General hospital
    • Beijing, Beijing, China, 100000
      • Beijing Military General Hospital
    • Beijing, Beijing, China, 100000
      • Dong Zhi Men Hospital of Beijing University of Chinese Medicine
    • Beijing, Beijing, China, 100000
      • PLA Air Force General Hospital
    • Beijing, Beijing, China, 100000
      • Pla Navy General Hospital
    • Beijing, Beijing, China, 100000
      • The First Affiliated Hospital of General Hospital of PLA
    • Beijing, Beijing, China, 100000
      • The Second Artillery General Hospital Of Chinese People's Liberation Army
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Xin Qiao Hospital Of Third Military Medical University
  • Fujian
    • Quanzhou, Fujian, China, 362008
      • Chinese People's Liberation Army No.180 Hospital
    • Xiamen, Fujian, China, 361001
      • Chinese People's Liberation Army No.174 Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
    • Lanzhou, Gansu, China, 730000
      • The Second Hospital of Lanzhou University
  • Guangxi
    • Guilin, Guangxi, China, 541000
      • Affiliated Hospital of Guilin Medical University
    • Nanning, Guangxi, China, 530000
      • The First Affiliated Hospital of Guangxi University of Chinese Medicine
    • Nanning, Guangxi, China, 530000
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Affiliated Hospital of Guiyang Medical College
    • Guiyang, Guizhou, China, 550000
      • Guizhou Province Hospital of Traditional Chinese Medicine
    • Guiyang, Guizhou, China, 550000
      • The Affiliated Baiyun Hospital of Guizhou Medical University
    • Zunyi, Guizhou, China, 563000
      • Affiliated Hospital of Zun Yi Medical College
  • Hainan
    • Haikou, Hainan, China, 570100
      • Hainan Medical College Affiliated Hospital
    • Haikou, Hainan, China, 570100
      • Hainan Provincial Nong Ken Hospital
  • Hebei
    • Chengde, Hebei, China, 067000
      • Affiliated Hospital of Cheng De Medical College
    • Qinhuangdao, Hebei, China, 066000
      • First Hospital of Qinhuangdao
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150000
      • Heilongjiang Provincial Academy of Traditional Chinese Medicine
    • Haerbin, Heilongjiang, China, 150000
      • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
  • Henan
    • Luoyang, Henan, China, 471000
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Xinxiang, Henan, China, 453000
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Hubei
    • Huanggang, Hubei, China, 438000
      • Huang Gang Central Hospital
    • Wuhan, Hubei, China, 430000
      • Hubei Provincial Hospital of TCM
    • Wuhan, Hubei, China, 430000
      • Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology
    • Wuhan, Hubei, China, 430000
      • Wuhan Integrated TCM & Western Medicine Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The Second Xiang Ya Hospital of Central South University
    • Changsha, Hunan, China, 410000
      • Xiang Ya Hospital Central South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014000
      • The first affiliated hospital of Baotou medical college
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Province Hospital of Traditional Chinese Medicine
    • Nantong, Jiangsu, China, 226000
      • Affiliated Hospital of Nantong University
    • Taizhou, Jiangsu, China, 225300
      • Jiangsu Taizhou People's Hospital
    • Taizhou, Jiangsu, China, 225300
      • Taizhou Traditional Chinese Medicine Hospital
    • Xuzhou, Jiangsu, China, 221000
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330000
      • Jiangxi Provincial People's Hospital
    • Nanchang, Jiangxi, China, 330000
      • Chinese People's Liberation Army No.94 Hospital
    • Pingxiang, Jiangxi, China, 337000
      • Jiangxi Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130000
      • The Second Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • The Second Hospital of Dalian Medical University
    • Dalian, Liaoning, China, 116000
      • The First Affiliated Hospital Of Dalian Medical University
    • Jinzhou, Liaoning, China, 121000
      • First Affiliated Hospital of Liaoning Medical University
    • Shenyang, Liaoning, China, 110000
      • The General Hospital Of Shenyang Military Region
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • Ningxia Hui Autonomous Region's Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Jinan General Hospital of PLA
    • Jinan, Shandong, China, 250000
      • Qi Lu Hospital of Shandong University
    • Jining, Shandong, China, 272000
      • Jining No.1 People's Hospital
    • Taian, Shandong, China, 271000
      • Chinese People's Liberation Army No.88 Hospital
    • Yantai, Shandong, China, 264000
      • Yantai Yu Huang Ding hospital
    • Zaozhuang, Shandong, China, 277100
      • Zaozhuang Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai East hospital
    • Shanghai, Shanghai, China, 200000
      • Children's Hospital of Fudan University
    • Shanghai, Shanghai, China, 200000
      • Chang Hai Hospital of the Second Military Medical University
    • Shanghai, Shanghai, China, 200000
      • Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200000
      • Shanghai Ninth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200000
      • Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200000
      • Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China, 030000
      • The Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Hospital of Integrated Traditional And Western Medicine
    • Taiyuan, Shanxi, China, 030000
      • The First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
    • Chengdu, Sichuan, China, 610000
      • The Third People's Hospital of Chengdu
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
    • Tianjin, Tianjin, China, 300000
      • The Second Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China, 300000
      • Tianjin Hospital of ITCWM, Nankai Hospital
  • Xinjiang
    • Shihezi, Xinjiang, China, 832000
      • The First Hospital of Shi He Zi Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abelmoschus manihot (AM); age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day; age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day; age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day	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.; Other Names: Huanghui capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24-h proteinuria from baseline after treatment	Baseline(week 0), week 12, week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
change in the serum creatinine level from baseline after treatment	Baseline(week 0), week 12, week 24
change in the estimated glomerular filtration rate (eGFR) from baseline after treatment	Baseline(week 0), week 12, week 24

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Xiangmei Chen, MD.& Ph.D, Chinese PLA General hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 30, 2014
• First Submitted That Met QC Criteria: August 30, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: safety; proteinuria; Chronic Kidney Disease; efficacy; Abelmoschus manihot
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: S2014-040-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The test has not been completed.