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Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Abelmoschus manihot (AM)
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Abelmoschus manihot, Chronic Kidney Disease, proteinuria, efficacy, safety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Hospital of Anhui Medical University
  • Beijing Military General Hospital
  • Chinese PLA General Hospital
  • Dong Zhi Men Hospital of Beijing University of Chinese Medicine
  • PLA Air Force General Hospital
  • PLA Navy General Hospital
  • The First Affiliated Hospital of General Hospital of PLA
  • The Second Artillery General Hospital Of Chinese People's Liberation Army
  • Xin Qiao Hospital Of Third Military Medical University
  • Chinese People's Liberation Army No.180 Hospital
  • Chinese People's Liberation Army No.174 Hospital
  • The First Hospital of Lanzhou University
  • The Second Hospital of Lanzhou University
  • Affiliated Hospital of Guilin Medical University
  • The First Affiliated Hospital of Guangxi Medical University
  • The First Affiliated Hospital of Guangxi University of Chinese Medicine
  • Affiliated Hospital of Guiyang Medical College
  • Guizhou Province Hospital of Traditional Chinese Medicine
  • The Affiliated Baiyun Hospital of Guizhou Medical University
  • Affiliated Hospital of Zun Yi Medical College
  • Hainan Medical College Affiliated Hospital
  • Hainan Provincial Nong Ken Hospital
  • Affiliated Hospital of Cheng De Medical College
  • First Hospital of Qinhuangdao
  • Heilongjiang Provincial Academy of Traditional Chinese Medicine
  • The First Affiliated Hospital Of Heilongjiang University of Chinese Medicine
  • The First Affiliated Hospital of Henan University of Science And Technology
  • The First Affiliated Hospital of Xinxiang Medical University
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Huang Gang Central Hospital
  • Hubei Provincial Hospital Of TCM
  • Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology
  • Wuhan Integrated TCM & Western Medicine Hospital
  • The Second Xiang Ya Hospital of Central South University
  • Xiang Ya Hospital Central South University
  • The First Affiliated Hospital of Baotou Medical College
  • Jiangsu Province Hospital of Traditional Chinese Medicine
  • Affiliated Hospital of Nantong University
  • Jiangsu Taizhou People's Hospital
  • Taizhou Traditional Chinese Medicine Hospital
  • Xuzhou Central Hospital
  • Chinese People's Liberation Army No.94 Hospital
  • Jiangxi Provincial People's Hospital
  • The First Affiliated Hospital Of Nanchang University
  • Jiangxi Pingxiang People's Hospital
  • The Second Hospital Of Jilin University
  • The First Affiliated Hospital of Dalian Medical University
  • The Second Hospital Of Dalian Medical University
  • First Affiliated Hospital of Liaoning Medical University
  • The General Hospital Of Shenyang Military Region
  • Ningxia Hui Autonomous Region's Hospital
  • Jinan General Hospital of PLA
  • Qi Lu Hospital of Shandong University
  • Jining No.1 People's Hospital
  • Chinese People's Liberation Army No.88 Hospital
  • Yantai Yu Huang Ding Hospital
  • Zaozhuang Municipal Hospital
  • Chang Hai Hospital of the Second Military Medical University
  • Children's Hospital of Fudan University
  • Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
  • Shanghai East Hospital
  • Shanghai Ninth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
  • Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
  • Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanxi Hospital of Integrated Traditional And Western Medicine
  • Shanxi Provincial People's Hospital
  • The First Hospital of Shanxi Medical University
  • The Second Hospital of Shanxi Medical University
  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
  • The third People's Hospital of Chengdu
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • The Second Hospital Of Tianjin Medical University
  • Tianjin Hospital of ITCWM, Nankai Hospital
  • The First Hospital of Shi He Zi Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang Provincial People's Hospital
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abelmoschus manihot (AM)

Arm Description

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

Outcomes

Primary Outcome Measures

Change in 24-h proteinuria from baseline after treatment

Secondary Outcome Measures

change in the serum creatinine level from baseline after treatment
change in the estimated glomerular filtration rate (eGFR) from baseline after treatment

Full Information

First Posted
August 30, 2014
Last Updated
May 31, 2016
Sponsor
Chinese PLA General Hospital
Collaborators
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02231138
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Abelmoschus manihot, Chronic Kidney Disease, proteinuria, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abelmoschus manihot (AM)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Abelmoschus manihot (AM)
Other Intervention Name(s)
Huanghui capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 24-h proteinuria from baseline after treatment
Time Frame
Baseline(week 0), week 12, week 24
Secondary Outcome Measure Information:
Title
change in the serum creatinine level from baseline after treatment
Time Frame
Baseline(week 0), week 12, week 24
Title
change in the estimated glomerular filtration rate (eGFR) from baseline after treatment
Time Frame
Baseline(week 0), week 12, week 24

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The test has not been completed.
Citations:
PubMed Identifier
24631042
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.
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Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

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