ITMCTR2000004214尚未招募未知
Efficacy and safety evaluation of Traditional Chinese Medicine treatment based on syndrome differentiation on early type 2 diabetic nephropathy: a randomized, double-blind, placebo-controlled study
Beijing Shijitan Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •1. Patients with type 2 diabetes mellitus diagnosed according to the World Health Organization (WHO) standard in 1999;
- •2. meet the diagnostic criteria of TCM syndrome of diabetic nephropathy in the guiding principles of clinical research of new Chinese medicine (2002 Edition);
- •3. Aged 18 to 75 years old men and women;
- •4. HbA1c 5.8% - 10% (including both ends); blood pressure < 160 / 110mmhg; triglyceride < 5.7mmol/l; stable standard treatment scheme in line with the prevention and treatment guidelines for type 2 diabetes mellitus, achieving the comprehensive control objectives recommended in the guidelines, without adjusting the treatment plan;
- •5. During screening, the average UACR of two random urine samples 30-300 mg / g;
- •6. Glomerular filtration rate (GFR) > 60 ml / min (calculated by EPI formula);
- •7. Receive a stable dose of medication for 8 consecutive weeks prior to the second visit to control hypertension, hyperglycemia and (if applicable) dyslipidemia;
- •8. The dosage of angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) was stable for 8 weeks before the second visit;
- •9. Be able to understand and follow the research process, participate in the research voluntarily and sign the informed consent form.
排除标准
- •1. Known or suspected allergy to test drug or related drug;
- •2. Participated in this experiment. Participation is defined as accepting random assignment;
- •3. Women who are pregnant, lactating or planning their pregnancies, or women who are fertile and do not take effective contraceptive measures;
- •4. Participated in any clinical trials of approved or not approved trial drugs within 30 days before screening;
- •5. Any disease determined by the researcher that may endanger the safety of the subject or affect the compliance with the study protocol;
- •6. Congenital or hereditary nephropathy, including polycystic kidney disease, autoimmune kidney disease (including glomerulonephritis), or congenital urinary tract malformation or urinary tract infection, or urolithiasis or gout;
- •7. Use traditional Chinese medicine for diabetic nephropathy within 30 days before screening;
- •8. Myocardial infarction, stroke, unstable angina or transient ischemic attack occurred within 60 days before screening;
- •9. Heart failure currently classified as NYHA grade IV;
- •10. Planned revascularization of coronary, carotid or peripheral arteries;
- •11. Current (or within 90 days) long-term or intermittent hemodialysis or peritoneal dialysis;
- •12. He is currently suffering from malignant tumor or has suffered from malignant tumor within 5 years before screening. Except basal cell and squamous cell skin cancer and carcinoma in situ;
- •13. Have received or are waiting for solid organ transplantation;
- •14. Combined use of angiotensin converting enzyme (ACE) inhibitor and angiotensin II receptor antagonist (ARB);
- •15. Type 1 diabetes mellitus and special type diabetes mellitus;
- •16. Liver enzymes (AST, ALT or ALP) increased more than 3 times, or patients with liver disease could not participate in this study;
- •17. Routine urine test: hematuria + + or above or WBC exceeding normal range;
- •18. Other system diseases (blood, digestion, respiration, circulation, mental nerve, etc.) are not suitable for the test;
- •19. Alcoholics and drug abusers.
研究者
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