Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

July 4, 2016 updated by: Chen Xiangmei

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

-IgA nephropathy is the most common primary glomerular disease in China, 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 IgA nephropathy in large scale samples with long time take.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The test has not been completed .

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Completed
        • The First Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230000
        • Completed
        • The Second Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100000
        • Completed
        • Beijing Chao-Yang Hospital
      • Beijing, Beijing, China, 100000
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Completed
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100000
        • Completed
        • Dong Zhi Men Hospital of Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 100000
        • Completed
        • Guang An Men Hospital China Academy of Chinese Medical Sciences
      • Beijing, Beijing, China, 100000
        • Completed
        • Pla Navy General Hospital
      • Beijing, Beijing, China, 100000
        • Recruiting
        • The Second Artillery General Hospital Of Chinese People's Liberation Army
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Completed
        • Da Ping Hospital Of Third Military Medical University
      • Chongqing, Chongqing, China, 400000
        • Completed
        • Yongchuan Hospital of Chongqing Medical University
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Recruiting
        • Chinese People's Liberation Army No.180 Hospital
        • Contact:
      • Xiamen, Fujian, China, 361000
        • Completed
        • Chinese People's Liberation Army No.174 Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The Second Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • 421 Hospital of PLA
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Province Hospital of Traditional Chinese Medicine(TCM)
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541000
        • Completed
        • Affiliated Hospital of Guilin Medical University
      • Nanning, Guangxi, China, 530000
        • Completed
        • The First Affiliated Hospital of Guangxi Medical University
      • Nanning, Guangxi, China, 530000
        • Completed
        • The First Affiliated Hospital of Guangxi University of Chinese Medicine
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Completed
        • Affiliated Hospital of Guiyang Medical College
      • Guiyang, Guizhou, China, 550000
        • Completed
        • The Affiliated Baiyun Hospital of Guizhou Medical University
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zun Yi Medical College
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570100
        • Completed
        • Hainan Medical College Affiliated Hospital
      • Haikou, Hainan, China, 570100
        • Completed
        • Hainan Provincial Nong Ken Hospital
    • Hebei
      • Chengde, Hebei, China, 067000
        • Completed
        • Affiliated Hospital of Cheng De Medical College
      • Qinhuangdao, Hebei, China, 066000
        • Completed
        • First Hospital of Qinhuangdao
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China, 050000
        • Completed
        • Hebei Province Hospital of Traditional Chinese Medicine
      • Shijiazhuang, Hebei, China, 050000
        • Completed
        • TCM Hospital of Shi Jia Zhuang City
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150000
        • Completed
        • Heilongjiang Provincial Academy of Traditional Chinese Medicine
      • Haerbin, Heilongjiang, China, 150000
        • Completed
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang, Henan, China, 471000
        • Completed
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Completed
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Huanggang, Hubei, China, 438000
        • Completed
        • Huang Gang Central Hospital
      • Wuhan, Hubei, China, 430000
        • Completed
        • Hubei Provincial Hospital of TCM
      • Wuhan, Hubei, China, 430000
        • Completed
        • Wuhan Integrated TCM & Western Medicine Hospital
      • Wuhan, Hubei, China, 430000
        • Completed
        • Zhong Nan Hospital of Wuhan University
    • Hunan
      • Changsha, Hunan, China, 410000
        • Completed
        • The Second Xiang Ya Hospital of Central South University
      • Changsha, Hunan, China, 410000
        • Completed
        • The Third Xiang Ya Hospital of Central South University
      • Changsha, Hunan, China, 410000
        • Completed
        • Xiangya Hospital Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Province Hospital of Traditional Chinese Medicine
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Completed
        • Jiangsu Provincial People's Hospital
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
      • Taizhou, Jiangsu, China, 225300
        • Completed
        • Jiangsu Taizhou People's Hospital
      • Taizhou, Jiangsu, China, 225300
        • Completed
        • Taizhou Traditional Chinese Medicine Hospital
      • Xuzhou, Jiangsu, China, 221000
        • Completed
        • Xuzhou Central Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Completed
        • Chinese People's Liberation Army No.94 Hospital
      • Nanchang, Jiangxi, China, 330000
        • Completed
        • Jiangxi Provincial People's Hospital
      • Nanchang, Jiangxi, China, 330000
        • Completed
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330000
        • Completed
        • The Second Affiliated Hospital of Nanchang University
      • Pingxiang, Jiangxi, China, 337000
        • Completed
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130000
        • Completed
        • Jilin Province People's Hospital
      • Changchun, Jilin, China, 130000
        • Completed
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130000
        • Completed
        • The Second Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Completed
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
      • Dalian, Liaoning, China, 116000
        • Completed
        • The First Affiliated Hospital of Dalian Medical University
      • Jinzhou, Liaoning, China, 121000
        • Completed
        • First Affiliated Hospital of Liaoning Medical University
      • Shenyang, Liaoning, China, 110000
        • Completed
        • People's Liberation Army No.202 Hospital
      • Shenyang, Liaoning, China, 110000
        • Completed
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China, 110000
        • Completed
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110000
        • Completed
        • The General Hospital Of Shenyang Military Region
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • Ningxia Hui Autonomous Region's Hospital
        • Contact:
      • Yinchuan, Ningxia, China, 750000
        • Completed
        • The General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China, 250000
        • Completed
        • Jinan General Hospital of PLA
      • Jinan, Shandong, China, 250000
        • Withdrawn
        • Qi Lu Hospital of Shandong University
      • Jining, Shandong, China, 272000
        • Completed
        • Affiliated Hospital of Jining Medical University
      • Jining, Shandong, China, 272000
        • Completed
        • Jining No.1 People's Hospital
      • Taian, Shandong, China, 271000
        • Completed
        • Chinese People's Liberation Army No.88 Hospital
      • Yantai, Shandong, China, 264000
        • Completed
        • Yantai Yu Huang Ding hospital
      • Zaozhuang, Shandong, China, 277100
        • Completed
        • Zaozhuang Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Completed
        • Chang Hai Hospital of the Second Military Medical University
      • Shanghai, Shanghai, China, 200000
        • Completed
        • Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200000
        • Completed
        • Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Completed
        • The First Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China, 030000
        • Completed
        • The Second Hospital of Shanxi Medical University
      • Xian, Shanxi, China, 710000
        • Completed
        • Shanxi Provincial People's Hospital
      • Xian, Shanxi, China, 710000
        • Completed
        • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Completed
        • Hua Xi Hospital of Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Completed
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Tianjin, China, 300000
        • Completed
        • The Second Hospital of Tianjin Medical University
      • Tianjin, Tianjin, China, 300000
        • Completed
        • Tianjin Hospital of ITCWM, Nankai Hospital
    • Xinjiang
      • Shihezi, Xinjiang, China, 832000
        • Recruiting
        • The First Hospital of Shi He Zi Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Completed
        • The Second Affiliated Hospital of Kunming Medical University
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • Yan'an Hospital of Kunming City
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Completed
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosed as chronic nephritic syndrome
  • IgA nephropathy diagnosed by kidney biopsy
  • Aged from 18 to 65 years，male or female
  • Blood pressure of ≤140/90mmHg
  • Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
  • 24-hour proteinuria ranged between 0.5g-3.0g
  • Obtaining the signed informed consent from patients

Exclusion Criteria:

  • Secondary IgA nephropathy
  • Be allergic to Huangkui Capsule or Losartan potassium tablet
  • Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
  • Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
  • Blood pressure <90/60mmHg
  • Serum potassium level > 5.5mmol / L
  • Serum albumin level <30g / L
  • Lactation, pregnancy or plans pregnancy during the study period
  • Unilateral or bilateral renal artery stenosis
  • 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
  • Participating in another clinical study in the same period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Abelmoschus manihot (AM)
Abelmoschus manihot (AM): Huangkui 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.
Drug: Abelmoschus manihot
Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
Other Names:
  • Huangkui Capsule
EXPERIMENTAL: Losartan
Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
Drug: Losartan
Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
Other Names:
  • Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 24-h proteinuria from baseline after treatment
Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum creatinine from baseline after treatment
Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Change in estimated glomerular filtration rate (eGFR) from baseline after treatment
Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Xiangmei

Collaborators

Jiangsu Suzhong Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Xiangmei Chen, MD.& Ph.D, Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

December 1, 2017

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)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2014-039-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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