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Clinical Trial Summary

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment with either tang shen prescription or placebo.


Clinical Trial Description

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/min) to evaluate the therapeutic effect of tang shen prescription.632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The study will last for 24 weeks. Subjects will be randomly divided into two groups, either tang shen prescription or placeboļ¼Œand both of them would be performed on a basic treatment which includes diabetes education, diabetic diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested monthly, and quantity of 24h urinary protein per three months. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT03009864
Study type Interventional
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Fengmei Lian, PHD
Phone 0086-010-88001402
Email lfm565@sohu.com
Status Not yet recruiting
Phase Phase 0
Start date January 2017
Completion date May 2020

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