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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| Zhengzhou City Hospital of Traditional Chinese Medicine | OTHER |
| Shijiazhuang City Hospital of Traditional Chinese Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangshen Prescription | Experimental | The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangshen Prescription | Drug | The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of albumin-to-creatinine ration | 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengmei Lian, PHD | Contact | 0086-010-88001402 | lfm565@sohu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31864393 | Derived | Jin D, Huang WJ, Meng X, Yang F, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial. Trials. 2019 Dec 21;20(1):756. doi: 10.1186/s13063-019-3821-6. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Baoding City Hospital of Traditional Chinese Medicine | UNKNOWN |
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| Changchun Hospital of Traditional Chinese Medicine | UNKNOWN |
| Xingtai City Hospital of Traditional Chinese Medicine | UNKNOWN |
| Medicine Zibo Wanjie Tumor Hospital | UNKNOWN |
| Zouping Country Hospital of Traditional Chinese Medicine | UNKNOWN |
| She Country Hospital of Traditional Chinese Medicine | UNKNOWN |
| Beijing Hospital of TCM | UNKNOWN |
| Baishi Hospital | UNKNOWN |
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| Placebos | Drug | 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. |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |