Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

NCT ID: NCT03164785

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2022-12-08

Brief Summary

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

Detailed 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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

Jinshuibao Capsule

Intervention Type: DRUG

1.98g t.i.d. p.o. for 6 months

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Jinshuibao Capsule

1.98g t.i.d. p.o. for 6 months

Intervention Type: DRUG

Other Intervention Names

Jinshuibao Jiaonang; Cordyceps sinensis; Artificial Cordyceps sinensis powder

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Zhiguang Zhou

Head of Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguang Zhou, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

JSB201601

Identifier Type: -

Identifier Source: org_study_id