Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
1 other identifier
interventional
1,500
1 country
13
Brief Summary
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2015
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 1, 2016
August 1, 2016
1.5 years
June 3, 2015
August 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
24-hour urinary protein excretion
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Secondary Outcomes (5)
Serum creatinine
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glomerular filtration rate
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Albumin
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glycated hemoglobin
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Symptom scores
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Other Outcomes (9)
Routine blood test
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Routine urine test
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Liver function
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
- +6 more other outcomes
Study Arms (1)
Shenyan kangfu Tablets
EXPERIMENTALShenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
Interventions
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
Eligibility Criteria
You may qualify if:
- Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- Aged from 18 to 70 years，male or female
- GFR≥45ml/min/1.73㎡
- g≤24 hours proteinuria≤3.0g
- glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
- Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
- Obtain the agreement of patients or their guardians, and signed informed consent file
You may not qualify if:
- Secondary nephropathy
- People allergic to Shenyankangfu tables
- 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
- Be participating in another clinical study at the same period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chen Xiangmeilead
- Tianjin TongRenTang Group Co., Ltd.collaborator
Study Sites (13)
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Daping Hospital,Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital Nanjing Military Command
Fuzhou, Fujian, China
174th hospital of the People's Liberation Army
Xiamen, Fujian, China
Beidaihe Sanatorium of Beijing Military Mrca
Qinhuangdao, Hebei, China
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
Henan Provincial People'S Hospital
Zhengzhou, Henan, China
Shandong Province Hospital
Jinan, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
LONGHUA Hospital Shanghai University of TCM
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 3, 2015
First Posted
September 1, 2016
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
September 1, 2016
Record last verified: 2016-08