NCT06006689招募中2 期
A Randomized, Double-blind, Multi-center, Standardise-loaded, Placebo-parallel Controlled Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 16
- 主要终点
- Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
研究概览
简要总结
This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Man or woman between 18-75 years-old
- •Subjects with type 2 diabetes mellitus
- •Subjects with a clinical diagnosis of diabetic kidney disease
- •eGFR≥ 45 mL/min/1.73 m2
- •UACR ≥ 30 mg/g but ≤ 300 mg/g
- •Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
- •Received Steady dose of ACEI or ARB therapy for chronic heart failure at least 2 weeks before receiving investigational drug
- •Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment
排除标准
- •Subjects with type 1 diabetes mellitus or other specific types of diabetes
- •Acute complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemia occurred in the past 3 months
- •HbA1c ≥8.5% or fasting blood glucose >11 mmol/L
- •Urinary sediment indicates "active" glomerulogenic hematuria
- •Subjects have been clinically confirmed cases of primary glomerular disease, secondary glomerular disease other than DKD or other systemic diseases
- •The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg or Hypotension with a systolic blood pressure <90mmHg and/or a diastolic blood pressure <60mmHg
- •ALT or AST> 2 times the upper limit of normal
- •Serum potassium> the upper limit of normal
- •Patients with unstable basic treatment for lowering blood glucose and blood lipids within the past 3 months, and patients with unstable basic treatment for lowering blood pressure within the past 1 month (changing the type of drugs, such as changing the β-receptor blockers to calcium ion antagonists, etc.)
- •Take the following medications within the last 2 weeks：a. Other drugs for the treatment of DKD (Finerenone, Keluoxin capsule, Qizhi Yishen capsule, SGLT2i drugs, GLP-1 drugs, etc.), b. Calcium oxybenzenesulfonate for the treatment of diabetic retinopathy, c. Chinese patent medicine, Chinese medicine decoction, formula granule and other Chinese medicine preparations with the same composition or function indications, d. Tripterygium wilfordii related preparations, Huangkui capsule
- •Patients who need to take antiplatelet drugs, the dose was stable for less than 1 month
- •Serious diseases of other systemic systems that may affect the judgment of efficacy and safety
- •A history of alcohol or drug abuse with a combination of mental illness and poor control
- •Allergic to the experimental drug or its ingredients
- •Women who are pregnant or breastfeeding, or who have a need to have children during the trial
- •Participating in other clinical studies and taking investigational drugs from other studies within 3 months prior to screening
- •The investigator deems that the patient is not suitable to participate in the study
研究组 & 干预措施
Placebo group
Placebo Comparator
Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
干预措施: Qishen Yiqi Dripping Pills placebo 3 bags (Drug)
Low dose group
Experimental
Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
干预措施: Low dose Qishen Yiqi Dripping Pills 3 bags (Drug)
High dose group
Experimental
High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
干预措施: High dose Qishen Yiqi Dripping Pills 3 bags (Drug)
结局指标
主要结局
Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
时间窗: Baseline to weeks 4, 8 and 12
Change in UACR from baseline to weeks 4, 8 and 12.
次要结局
- Ratio of subjects with UACR decrease of more than 30% from baseline.(Baseline to weeks 4, 8 and 12)
- Change in eGFR(estimated glomerular filtration rate).(Baseline to weeks 4, 8 and 12)
- Ratio of subjects with UACR returned to normal.(Baseline to weeks 4, 8 and 12)
- TCM syndrome(Baseline to weeks 4, 8 and 12)
- Ratio of subjects from microalbuminuria stage to macroalbuminuria(Baseline to weeks 4, 8 and 12)
- Change in Traditional Chinese Medicine Syndrome Score(Baseline to weeks 4, 8 and 12)
研究者
研究点 (16)
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