研究疾病:
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糖尿病肾脏疾病
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研究疾病代码:
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Target disease:
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Diabetic kidney disease
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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通过前瞻性、随机、双盲、安慰剂对照临床试验,评价陈氏糖肾方对CKD3~4期的DKD患者肾功能及尿蛋白的作用及其安全性,为陈氏糖肾方治疗DKD提供高级别循证医学证据,从而为防治DKD提供新途径。
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Objectives of Study:
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Through a prospective, randomized, double-blind, placebo-controlled clinical trial, to evaluate the effect and safety of Chen's Tangshen Recipe on renal function and urinary protein of DKD patients with CKD stage 3-4, so as to provide high-level evidence-based medical evidence for the treatment of DKD by Chen's Tangshen recipe and provide a new way for the prevention and treatment of DKD.
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药物成份或治疗方案详述:
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所有患者均接受基础治疗及运动饮食指导,随机分组,受试者服用中药颗粒剂或安慰剂,所有试验用药均按GMP标准生产,对照组(安慰剂组):淀粉糊精等制成颗粒剂;试验组(陈氏糖肾方组):处方:生黄芪45克、黄精18、灵芝30克、川芎15克、葛根15克、山萸肉15克、金蝉花15克、桑螵蛸9克、积雪草30克、 莪术12克、牛蒡子15克、三七粉2克。水煎后,制成颗粒剂,每日分两次服用。
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Description for medicine or protocol of treatment in detail:
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All patients received basic treatment and exercise and diet guidance; And according to random grouping, take traditional Chinese medicine granules or placebo, all experimental drugs are produced according to GMP standards, and the control group (placebo group): starch dextrin, etc. are made into granules; Experimental group (Chen's Tangshen prescription group): Prescription: 45 grams of raw Astragalus, 18 grams of polygonatum, 30 grams of Ganoderma lucidum, 15 grams of Ligusticum chuanxiong, 15 grams of Pueraria, 15 grams of Cornus, 15 grams of cicada flower, 9 grams of cuttlebone, 30 grams of Centella asiatica, 12 grams of zedoary, 15 grams of Arctium lappa, 2 grams of Panax Notoginseng Powder. After being boiled in water, it is made into granules and taken twice a day.
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纳入标准:
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(1)临床诊断为CKD3~4期的DKD患者
(2)年龄≥18周岁且≤ 80周岁,男女不限;
(3)2型糖尿病患者,规范服用降糖药物或胰岛素治疗半年及以上,HbA1C≤8%;
(4)24小时尿蛋白定量≥0.3克
(5)患者知情同意并签署知情同意书。
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Inclusion criteria
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(1) DKD patients with clinical diagnosis of CKD stage 3~4
(2) Aged 18 to 80 years old;
(3)Patients with type 2 diabetes who have been taking antidiabetic drugs or insulin treatment for half a year or more, with HbA1c≤8%;
(4) Patients with 24-hour urine protein quantification≥0.3g
(5)The patients were informed and signed the informed consent.
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排除标准:
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1.1型糖尿病患者;
2.肝功能检查结果异常(AST或ALT或碱性磷酸酶 >3倍ULN),或其它已知的急慢性活动性肝炎、肝硬化的患者;
3.既往有使用ACEI/ARB类药物后2~3个月内eGFR下降>30%的病史;
4.因肾病或肾移植使用激素或免疫抑制剂者;
5.筛选时患有其它慢性肾病(如慢性肾小球肾炎、慢性肾盂肾炎、缺血性肾病等);
6.筛选前血压低于110/60mmHg(未使用降压药物)的患者;
7.筛选前两周前血压持续高于180/100mmHg者;
8.筛查期间血钾水平>5.5 mmol/L者;
9.筛选前6个月内,有发生严重的急性糖尿病并发症(酮症酸中毒、乳酸性酸中毒、高渗性非酮症糖尿病昏迷、低血糖昏迷)患者;
10.筛选前3个月内有发生急性冠脉综合征、心力衰竭(NYHA评分III-IV级),或因心脏相关疾病行手术治疗、脑卒中或脑卒中预后不良患者;
11.筛选前有精神疾病史,或语言障碍而无法合作或不愿合作者;
12.筛选前有自身免疫性疾病史(如系统性红斑狼疮病史等);
13.筛选前两年内有恶性肿瘤疾病史者
14.HIV患者;
15.对试验用药品过敏者;
16.正在参加其他药物临床试验者或筛选前3个月内参加过其他药物试验者 (指入组且接受试验药物治疗者);
17.半年内有妊娠计划、妊娠期或哺乳期女性患者;
18.研究者判断不适宜进行本试验的其他情况。
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Exclusion criteria:
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1. Patients with type 1 diabetes;
2. Abnormal liver function test results (AST or ALT or alkaline phosphatase > 3 times ULN), or other known patients with acute and chronic active hepatitis and cirrhosis;
3. Previous history of EGFR decline > 30% within 2-3 months after using ACEI / ARB drugs;
4. Those who use hormone or immunosuppressant due to kidney disease or kidney transplantation;
5. Other chronic kidney diseases (such as chronic glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.) during screening;
6. Patients with blood pressure lower than 110 / 60mmHg (without antihypertensive drugs) before screening;
7. Those whose blood pressure was continuously higher than 180 / 100mmHg two weeks before screening;
8. Those with blood potassium level > 5.5 mmol / L during screening;
9. Patients with severe acute diabetes complications (ketoacidosis, lactic acidosis, hypertonic nonketotic diabetes coma, hypoglycemic coma) within 6 months before screening;
10. Patients with acute coronary syndrome, heart failure (NYHA score III-IV), or surgical treatment for heart related diseases, stroke or poor prognosis of stroke within the first 3 months of screening;
11. Those who have a history of mental illness or language disorder before screening and are unable to cooperate or unwilling to cooperate;
12. History of autoimmune diseases (such as systemic lupus erythematosus) before screening;
13. Those with a history of malignant tumor disease within the previous two years were screened
14. HIV patients;
15. Those who are allergic to the test drug;
16. Those who are participating in clinical trials of other drugs or who have participated in other drug trials within 3 months before screening (refer to those who are enrolled in the group and receive treatment of test drugs);
17. Female patients with pregnancy plan, pregnancy or lactation within half a year;
18. Other conditions that the investigator judges are not suitable for this test.
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研究实施时间:
Study execute time:
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从From
2022-08-15
至To
2025-04-30
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征募观察对象时间:
Recruiting time:
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从From
2022-08-15
至To
2025-01-31
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