Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

June 29, 2015 updated by: Chen Xiangmei, Chinese PLA General Hospital

Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial

-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.

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.

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.
720

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.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Beijing, Beijing, China, 100853
        • Recruiting
        • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • xiangmei chen, doctor
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Friendship,Capital Medical University
      • Beijing, Beijing, China
        • Not yet recruiting
        • Xiyuan Hospital CACMS
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Daping Hospital,Research Institute of Surgery Third Military Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fuzhou General Hospital Nanjing Military Command
      • Xiamen, Fujian, China
        • Recruiting
        • 174th hospital of the People's Liberation Army
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Province Hospital of Chinese Medical
    • Hebei
      • Qinhuangdao, Hebei, China
        • Recruiting
        • Beidaihe Sanatorium of Beijing Military Mrca
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Third Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Heilongjiang University of Chinese Medicine
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Recruiting
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Provincil People'S Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The Second Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • First Affilated Hospital of Dalian Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xijing Hospital
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China
        • Recruiting
        • Tangdu Hospital
      • Xi'an, Shaanxi, China
        • Recruiting
        • Shaanxi Traditional Chinese Medicine Hospital
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Province Hospital
      • Jinan, Shandong, China
        • Recruiting
        • Teaching Hospital of Shandong University of Traditional Chinese Medicine
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Changhai Hospital of Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • LONGHUA Hospital Shanghai University of TCM
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
      • Shanghai, Shanghai, China
        • Recruiting
        • Shugaung Hospital
      • Shanghai, Shanghai, China
        • Recruiting
        • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • First Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
      • Taiyuan, Shanxi, China
        • Recruiting
        • Second Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Hospital of Integrated Traditional and Westem Medicine
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • General Hospital of Chengdu Military Region of PLA
      • Chengdu, Sichuan, China
        • Recruiting
        • Teaching Hospital of Chengdu University of T.C.M
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of TCM
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Tongde Hospital of Zhejiang Province
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Hospital of Traditional Chinese Medicine
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provncial 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

  • Diagnosed with primary glomerulonephritis
  • Aged from 18 to 70 years，male or female
  • Blood pressure can be controlled ≤140/90mmHg
  • GFR≥45ml/min/1.73㎡
  • 0.5g≤24 hours proteinuria≤3.0g
  • Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  • Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  • secondary nephropathy
  • Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
  • Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
  • Take renin-angiotensin system blockers in last 4 weeks
  • Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  • Pregnant or lactating women
  • Allergic predisposition or known to be allergic to the drug composition
  • Blood presser <90/60mmHg
  • With unilateral or bilateral renal artery stenosis
  • With mental disorders and poor compliance
  • Be suspected or confirmed with alcohol, drug abuse history
  • Be participating in another clinical study at 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 Assignment
  • Masking: Quadruple

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: Shenyankangfu tablets and Losartan potassium 100mg
Drug: Shenyankangfu tablets and Losartan potassium 100mg
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Shenyankangfu tablets and Losartan potassium 50mg
Drug: Shenyankangfu tablets and Losartan potassium 50mg
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab, po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Losartan potassium 50mg
Drug: Losartan potassium 50mg
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab,po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Shenyankangfu tablets
Drug: Shenyankangfu tablets
Shenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
Experimental: Losartan potassium 100mg
Drug: Losartan potassium 100mg
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.

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
changes of 24 hours proteinuria after the treatment
Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment
0,4,8,12,24,36,48 weeks after the enrollment

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
changes of serum creatinine after treatment
Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment
0,4,8,12,24,36,48 weeks after the enrollment
changes of eGFR after the treatment
Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment
0,4,8,12,24,36,48 weeks after the enrollment
changes of Traditional Chinese Medicine syndrome scores after the treatment
Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment
0,4,8,12,24,36,48 weeks after the enrollment

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.
Chinese PLA General Hospital

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.
Tianjin TongRenTang 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, Doctor, State Key Laboratory of Kidney Diseases,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.
February 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, 2015

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).
February 12, 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.
February 12, 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.
February 14, 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 1, 2015

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.
June 29, 2015

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.
June 1, 2015

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.
  • S2013-055-03

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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