Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
NCT ID: NCT02885857
Last Updated: 2016-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1500 participants
INTERVENTIONAL
2015-06-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
Shenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
Interventions
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Shenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Tianjin TongRenTang Group Co., Ltd.
UNKNOWN
Chen Xiangmei
OTHER
Responsible Party
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Chen Xiangmei
professor
Principal Investigators
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YongLi Zhan, investigator
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
HongTao Yang, investigator
Role: PRINCIPAL_INVESTIGATOR
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Meng Liang, investigator
Role: PRINCIPAL_INVESTIGATOR
174th hospital of the People's Liberation Army
Lu Ma, investigator
Role: PRINCIPAL_INVESTIGATOR
Beidaihe Sanatorium of Beijing Military Mrca
LiQun Song, investigator
Role: PRINCIPAL_INVESTIGATOR
Heilongjiang University of Chinese Medicine
QiaoLing Zhou, investigator
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Ping Luo, investigator
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Jilin University
RongShan Li, investigator
Role: PRINCIPAL_INVESTIGATOR
Shanxi provincial peple's hospital
XiaoHong Cheng, investigator
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Traditional Chinese Medicine Hospital
Jie Wu, investigator
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
Beijing, Beijing Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S2015-023-02
Identifier Type: -
Identifier Source: org_study_id
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