Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Name of Investigational Products Huangkui capsule.

2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)

3. Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.

Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy

4. Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

1. Aged 18 to 75 years old, male or female

2. Meet the diagnostic criteria of type 2 diabetes published by the World Health Organization (WHO) in 1999: fasting plasma glucose>126mg/dL (or>7.0mmol/L), 2h postprandial blood glucose>200mg/dL (or>11.1mmol/L), or 2h blood glucose in OGTT test>200mg/dL(11.1mmol/L), random blood glucose test≥200mg/dL(11.1mmol/L)

3. Meet Diabetic Kidney Disease (DKD) and the United States Diabetes Association (ADA) and the American Kidney Foundation (NKF) diagnostic criteria in 2007 ; 300mg/g ≤ ACR <2000mg/g

4. e-GFR>30 mL/min (CKD-Epi formula),

5. Glycated hemoglobin ≤8.5%

6. Agree to sign informed consent form.

Exclusion Criteria:

1. Type 1 diabetes

2. Other secondary glomerulonephritis caused by Non-diabetes disease;

3. Taking Huangkui capsule, ACEI and / or ARB drugs within 2 months;

4. Taking glucocorticoid, immunosuppressive agents and Tripterygium wilfordii drug history within one month;

5. Taking three or more antihypertensive drugs, but the blood pressure is still>160/90mmHg

6. With other diseases, syndromes, or comorbidities that may affect the diagnosis and therapeutic effect of the target indications

7. The treatments received may affect the evaluation of efficacy and safety endpoints

8. With phychological or pathological conditions which may affect the evaluation of efficacy endpoints and safety endpointssuch as the menstrual period, or heart, brain, liver and hematopoietic system and other serious primary disease

9. With high risk, such as pregnant women or childbearing during the trial, be allergy to the Abelmoschus Moschatus Capsule and irbesartan, in the dangerous condition with unexpected accidents.

10. Alcohol or drug abuse

11. Noncompliance, such as unwilling to accept research procedures or suffering from mental illness and other diseases

12. Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons;

13. Is participating in another clinical study.