Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 24H urine total protein
研究概览
简要总结
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.
详细描述
The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identify the diagnosis of type 2 diabetes;
- •It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
- •eGFR ≥ 30 ml / min / 1.73 m2;
- •Age 18-75 years old, gender ＆ethnicity are not limited;
- •glycated hemoglobin ≤ 10%;
- •Blood pressure is controlled below 130/80mmHg
排除标准
- •Combine other ACEI and ARB application indications other than hypertension;
- •Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
- •Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
- •Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
- •Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
- •Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
- •pregnant or lactating women;
- •Patients who accepted other clinical trial studies on going ;
- •Patients who combined with serious diseases and dysfunctions in other organs.
研究组 & 干预措施
ShenqiDihuang Decoction
ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks
干预措施: ShenqiDihuang Decoction (Drug)
ShenqiDihuang Decoction placebo
ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks
干预措施: ShenqiDihuang Decoction placebo (Drug)
结局指标
主要结局
24H urine total protein
时间窗: 24 weeks
t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients
次要结局
未报告次要终点