Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

Central South University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Treatments: Drug: Jinshuibao Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03164785

JSB201601

Details and patient eligibility

About

The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.

Full description

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.

Enrollment: 202 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subjects with written informed consent.

2. Type 2 diabetes according to 1999 WHO criteria.

3. Age: 30-75 years.

4. HbA1c < 11%.

5. 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 ㎡.

6. Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.

7. Childbearing-age women with contraceptive measures.

Exclusion Criteria：

1. Type 1 Diabetes Mellitus.
2. Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
3. Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.]
4. Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
5. Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
6. Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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

Treatment:

Drug: Jinshuibao Capsule

Control Group

No Intervention group

Description:

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