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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885857
Recruitment Status : Unknown
Verified August 2016 by Chen Xiangmei, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Tianjin TongRenTang Group Co., Ltd.
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital

Brief Summary:
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Shenyan Kangfu Tablet Phase 4

Detailed Description:

Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.

Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Shenyan kangfu Tablets
Shenyan Kangfu Tablets;Each weighing 0.48g;Oral;Once five, three times a day
Drug: Shenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.




Primary Outcome Measures :
  1. 24-hour urinary protein excretion [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]

Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  2. Glomerular filtration rate [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  3. Albumin [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  4. Glycated hemoglobin [ Time Frame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times ]
    Observations of the project value and the percentage change in value before and after the treatment.

  5. Symptom scores [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]

Other Outcome Measures:
  1. Routine blood test [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  2. Routine urine test [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  3. Liver function [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  4. Renal function tests [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  5. Potassium detection [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  6. blood glucose testing [ Time Frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times ]
  7. Electrocardiograph [ Time Frame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times ]
  8. chest radiography [ Time Frame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times ]
  9. Adverse events / adverse reactions [ Time Frame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times ]
    Follow-up 3 times.Subject at any time to contact your doctor.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;
  2. Aged from 18 to 70 years,male or female
  3. GFR≥45ml/min/1.73㎡
  4. 0.5g≤24 hours proteinuria≤3.0g
  5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
  6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  7. Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  1. Secondary nephropathy
  2. People allergic to Shenyankangfu tables
  3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  4. Pregnant or lactating women
  5. Be participating in another clinical study at the same period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885857


Contacts
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Contact: Jie Wu, chaieman 18210128683 wujie301@126.com
Contact: SiJi Li, director 13821669488 miaoshujie@yeah.net

Locations
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China, Beijing
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: jie wu, doctor       wujie301@163.com   
Principal Investigator: xiangmei chen, doctor         
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China
China, Chongqing
Daping Hospital,Research Institute of Surgery Third Military Medical University Recruiting
Chongqing, Chongqing, China
China, Fujian
Fuzhou General Hospital Nanjing Military Command Recruiting
Fuzhou, Fujian, China
174th hospital of the People's Liberation Army Recruiting
Xiamen, Fujian, China
China, Hebei
Beidaihe Sanatorium of Beijing Military Mrca Recruiting
Qinhuangdao, Hebei, China
China, Heilongjiang
Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China
China, Henan
Henan Provincial People'S Hospital Recruiting
Zhengzhou, Henan, China
China, Shandong
Shandong Province Hospital Recruiting
Jinan, Shandong, China
China, Shanghai
Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
LONGHUA Hospital Shanghai University of TCM Recruiting
Shanghai, Shanghai, China
China, Shanxi
First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China
China, Tianjin
First Teaching Hospital of Tianjin University of TCM Recruiting
Tianjin, Tianjin, China
Sponsors and Collaborators
Chen Xiangmei
Tianjin TongRenTang Group Co., Ltd.
Investigators
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Principal Investigator: YongLi Zhan, investigator Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigator: HongTao Yang, investigator First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Principal Investigator: Meng Liang, investigator 174th hospital of the People's Liberation Army
Principal Investigator: Lu Ma, investigator Beidaihe Sanatorium of Beijing Military Mrca
Principal Investigator: LiQun Song, investigator Heilongjiang University of Chinese Medicine
Principal Investigator: QiaoLing Zhou, investigator Xiangya Hospital of Central South University
Principal Investigator: Ping Luo, investigator Second Hospital of Jilin University
Principal Investigator: RongShan Li, investigator Shanxi provincial peple's hospital
Principal Investigator: XiaoHong Cheng, investigator Shaanxi Traditional Chinese Medicine Hospital
Principal Investigator: Jie Wu, investigator Chinese PLA General Hospital

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Responsible Party: Chen Xiangmei, professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02885857    
Other Study ID Numbers: S2015-023-02
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency