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Astragali Radix and Panax notoginseng combination for the treatment of diabetic nephropathy: clinical randomized controlled trial and mechanism study

Astragali Radix and Panax notoginseng combination for the treatment of diabetic nephropathy: clinical randomized controlled trial and mechanism study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029417
Enrollment
Unknown
Registered
2020-01-30
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic nephrology

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Individuals who meet all the following inclusion criteria are enrolled in the trial: 1.Aged >= 18 and 30 mg/g and = 60 mL/min/1.73 m2 (CKD-EPI formula); 6.Before screening, blood pressure is within the following range: Blood pressure: systolic blood pressure 110-160 mmHg, diastolic blood pressure 60-100 mmHg; 7.Participants should sign the informed consent before the commencenent of the study voluntarily, understand the procedures and methods of the study, and are willing to complete this study in strict accordance with the clinical research protocol.

Exclusion criteria

Exclusion criteria: Individuals who meet one of the following conditions should not be enrolled in the trial: 1.Type 1 diabetes; 2.Serum potassium >= 5.5 mmol/l after repeatedly potassium lowering treatment, or serum potassium 3 fold)or other known acute/chronic active hepatitis and cirrhosis during screening; 4. Acute urinary tract infection within 2 weeks before randomization; 5. Other chronic kidney diseases (such as glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.) during screening; 6.Blood pressure <= 110/60mmHg before screening; 7.History of severe acute diabetes complications (ketoacidosis, lactic acidosis, hypertonic non ketotic diabetes coma, hypoglycemic coma) within 6 months before screening; 8.Severe comorbid diseases: acute coronary syndrome (myocardial infarction, unstable angina pectoris), heart failure (NYHA III-IV), or surgical history for heart related diseases, stroke or transient ischemic attack within 3 months before screening; 9.History of mental illness or language barriers and are unable to cooperate or unwilling to cooperate; 10.History of rheumatic diseases (such as systemic lupus erythematosus); 11.History of malignant tumors or receiving antineoplastic drugs and/or surgical treatment within 5 years; 12.History of organ transplantation; 13.Allergic to the test drugs; 14.Those who are participating in other drug clinical trials or have participated in other drug trials within 3 months before screening (enrolled in the group and treated with test drugs); 15.Pregnant or lactating female patients; 16.Using two or more anticoagulant or antiplatelet drugs; 17.Other conditions that are not suitable for this test judged by the researchers.

Design outcomes

Primary

MeasureTime frame
UACR;

Secondary

MeasureTime frame
TCM syndrome score;uric microalbumin in 24h;urinary protein in 24h;eGFR;

Countries

China

Contacts

Public ContactGui Dingkun

Shanghai Sixth People's Hospital

dingkungui@sjtu.edu.cn+86 18017579169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026