Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment:subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling |
|
| Control Group | No Intervention | Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jinshuibao Capsule | Drug | 1.98g t.i.d. p.o. for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Subjects with written informed consent.
Type 2 diabetes according to 1999 WHO criteria.
Age: 30-75 years.
HbA1c < 11%.
Stage III diabetic kidney disease:
5.1 microalbuminuria: 30 mg / g < urinary albumin creatinine ratio (ACR) < 300 mg / g, positive for at least two in three times.
5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡.
Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.
Childbearing-age women with contraceptive measures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhiguang Zhou, MD/PhD | Second Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
The results belongs to the principal investigator and collaborators.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599929 | CME-1 polysaccharide, Cordyceps sinensis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |