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

Tasly Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: High dose Qishen Yiqi Dripping Pills 3 bags; Drug: Low dose Qishen Yiqi Dripping Pills 3 bags; Drug: Qishen Yiqi Dripping Pills placebo 3 bags

Study type: Interventional

Funder types: Industry

Identifiers

NCT06006689

TSL-TCM-QSYQDW-DKD-Ⅱ

Details and patient eligibility

About

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)

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: Qishen Yiqi Dripping Pills placebo 3 bags

Low dose group

Experimental group

Description:

Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: Low dose Qishen Yiqi Dripping Pills 3 bags

High dose group

Experimental group

Description:

High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: High dose Qishen Yiqi Dripping Pills 3 bags