The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage

Study Overview
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Brief Summary
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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.

Detailed Description
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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 placebo，and 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.

Official Title
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The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage

Conditions
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Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Tangshen Prescription
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 diabetic Kidney Disease in early stage; Aged 30-70; Signed the informed consent. Exclusion Criteria: Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria. Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the serum transaminase was two times larger than the normal valuet、serum creatinine concentration greater than the upper limit of normal value and psychiatric disease. Women with Pregnancy or prepare for pregnancy or lactating. Degree of renal failure have developed to the stage of hypoxemia and uremia. Patients participate in other clinical researchers within a month. Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month. Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month. Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg. Patients with diabetic ketosis, ketoacidosis and severe infections within a month. Patients addicting alcohol, psychoactive substances within 5 years. According to the researcher's judgment, there are other diseases or situations that can reduce the possibility of entering the group or complicate the group, such as frequent changes in the working environment and unstable living environment.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tangshen Prescription<br>The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day. | Drug: Tangshen Prescription<br>* The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.<br>Drug: Placebos<br>* Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.<br>|
| Placebo Comparator: Placebo<br>Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day. | Drug: Tangshen Prescription<br>* The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.<br>Drug: Placebos<br>* Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of albumin-to-creatinine ration |  | 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants of diabetic kidney disease in macroalbuminuria stage |  | 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks | 
| number of participants whose microalbuminuria excretion rate < 20ug/min |  | 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks | 
| change of GFR |  | 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks | 
| the rate of doubling the baseline with serum creatinine value |  | 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Kidney Disease, TCM, RCT