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Clinical Trial Details

Trial ID: L5631
Source ID: NCT03164785
Associated Drug: Jinshuibao Capsule
Title: Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Diabetic Kidney Disease
Interventions: DRUG: Jinshuibao Capsule
Outcome Measures: Primary: Change in urine albumin creatine ratio (ACR)., First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial)., Baseline and 1,2,3,6 months. | Secondary: The incidence of ≧30% decline in eGFR from baseline., Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) \[CKD-EPI creatinine-cystatin equation (2012)\]., half a year|Change in urine α1-microglobulin., Baseline and 1,2,3,6 months.|Change in urine β2-microglobulin., Baseline and 1,2,3,6 months.|Change in urine N-acetyl-β-D-glucosidase., Baseline and 1,2,3,6 months.|Change in urine neutrophil gelatinase-associated lipocalin., Baseline and 1,2,3,6 months.|Change in inflammation level., Change in hs-CRP level., Baseline and 1,2,3,6 months.|Change in HbA1c., Baseline and 1,3,6 months.|Change in blood pressure control., Baseline and 1,2,3,6 months.|Change in blood lipids., Baseline and 1,3,6 months.|Life quality evaluation, Change in SF-36 Scale score., Baseline and 6 months.|Incidence of Treatment-Emergent Adverse Events, Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc., half a year
Sponsor/Collaborators: Sponsor: Second Xiangya Hospital of Central South University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 202
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-07-24
Completion Date: 2022-12-08
Results First Posted:
Last Update Posted: 2024-01-03
Locations: The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
URL: https://clinicaltrials.gov/show/NCT03164785