Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Qishen Yiqi Dripping Pills placebo 3 bags
* Drug: Low dose Qishen Yiqi Dripping Pills 3 bags
* Drug: High dose Qishen Yiqi Dripping Pills 3 bags


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day | Drug: Qishen Yiqi Dripping Pills placebo 3 bags<br>* Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks<br>* Other names: Placebo group;|
| Experimental: Low dose group<br>Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day | Drug: Low dose Qishen Yiqi Dripping Pills 3 bags<br>* Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks<br>* Other names: Low dose group;|
| Experimental: High dose group<br>High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day | Drug: High dose Qishen Yiqi Dripping Pills 3 bags<br>* High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks<br>* Other names: High dose group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio). | Change in UACR from baseline to weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects with UACR returned to normal. | Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 | 
| Ratio of subjects with UACR decrease of more than 30% from baseline. | Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 | 
| Ratio of subjects from microalbuminuria stage to macroalbuminuria | Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 | 
| Change in eGFR(estimated glomerular filtration rate). | Change in eGFR from baseline to weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 | 
| Change in Traditional Chinese Medicine Syndrome Score | Change in Traditional Chinese Medicine Syndrome Score from baseline to weeks 4, 8 and 12. There were 9 clinical primary symptoms, 7 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms and secondary symptoms scored as without 0, light 2, medium 4, heavy 6 points. Tongue picture and pulse condition did not count. | Baseline to weeks 4, 8 and 12 | 
| TCM syndrome | Number and ratio of subjects with Clinical recovery, obvious effect, effective or ineffective in curative effect of TCM syndrome at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |