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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The test has not been completed .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiangmei Chen, MD.&Ph.D
  • Phone Number: +86-10-66935462
  • Email: xmchen301@126.com

Study Contact Backup

  • Name: Xuefeng Sun, MD.&Ph.D
  • Phone Number: +86-10-66937077
  • Email: xfssun@126.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chen Xiangmei

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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