Status:
RECRUITING
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06006689
Start Date
September 4 2023
End Date
September 1 2025
Last Update
March 13 2024
Active Locations (16)
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1
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
2
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
3
The Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
4
Hebei Province Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China