ITMCTR2000003199尚未招募4 期
Effcacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis: a Multicenter Randomized Controlled Clinical Trial
Shanghai Sixth People's Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 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
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •1. Aged >= 18 years old and <= 70 years old;
- •2. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician;
- •3. Stage 3b-4 chronic kidney disease, that is, patients with eGFR < 45 and >= 15mL/min/1.73 m2 (2012 KDIGO standard);
- •4. 24-hour urinary protein quantification < 3g during the screening period;
- •5. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range:
- •blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg;
- •fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%;
- •LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L);
- •uric acid < 420 mol/L;
- •6. Patients who have signed the informed consent.
排除标准
- •1. Pregnant and lactating women, and women of reproductive age who are unwilling to take reliable contraceptive measures;
- •2. Patients with known allergy to Jinshuibao;
- •3. Natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment were used in two weeks before enrollment;
- •4. Patients who received glucocorticoids, immunosuppressants or tripterygium wilfordii preparations 3 months prior to enrol, or patients who have been confirmed to receive glucocorticoids, immunosuppressants or tripterygium wilfordii preparations;
- •5. Patients with gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II and below), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea and gastrointestinal surgery;
- •6. With a history of organ transplant, including kidney transplant;
- •7. With severe diseases of the heart, brain, liver and hematopoietic system or other serious diseases affecting survival: for example, patients with known malignant tumors, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack occurred within 6 months;
- •8. For patients whose disease progresses too rapidly as judged by the clinician, such as eGFR decreases by more than 5ml/min/1.73m2 in the previous year;
- •9. Patients who participated in other clinical trials within 3 months;
- •10. In addition to the above, patients who evaluated by the researchers are not eligible to participate in the clinical trial.
研究者
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