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Clinical study on the treatment of diabetic kidney disease with Qing-Re-Xiao-Zheng-Yi-Qi formula

Clinical study on the treatment of diabetic kidney disease with Qing-Re-Xiao-Zheng-Yi-Qi formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000340
Enrollment
Unknown
Registered
2024-08-31
Start date
2024-09-05
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Diabetic kidney disease

Interventions

Control group:Western medicine standard treatment + Chinese medicine granule simulation agent
Experimental group:Western medicine standard treatment + Qing-Re-Xiao-Zheng-Yi-Qi formula

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)Meet the diagnostic criteria of DKD (2)AER 30-300mg/ 24h or ACR 30-300mg/g (or 3-30mg/mmol) (3)eGFR=60ml·min-1·(1.73 m2)-1 (4)HbA1c (glycated hemoglobin) =8.5% (5)18 years = age =75 years (6)TCM syndrome of Qi and Yin deficiency stasis and heat interjunction (7)The subject gives informed consent and signs the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) Non-DKD (rapid deterioration of renal function sudden increase of urinary protein accompanied by survival) was considered in clinical diagnosis Motile urinary sediment etc.) (2) Complications such as severe infection severe anemia electrolyte disturbance occurred within the past 4 weeks (3) renal artery stenosis (4) Serum albumin < 20g/L (5) Accompanied by acute kidney injury oliguria or anuria severe edema massive pleural effusion and abdominal accumulation Liquid person (6) Used glucocorticoids immunosuppressants and tripterygium wilfordis preparations in the past 12 weeks (7) Patients with serious heart brain liver and hematopoietic system diseases within three months: stroke Transient ischemic attack significant neurological dysfunction myocardial infarction and instability after stroke Sexual angina pectoris ischemic heart disease after coronary artery bypass or PCI congestive heart failure (heart function ?-IV) Grade I NYHA rating) aminotransferase increased to more than 2 times the upper limit of the normal range severe thrombocytopenia (PLT<10×109/L) abnormal coagulation function or active digestion within three months Blood patients (8) accompanied by wasting diseases such as tuberculosis or a history of mental illness (9) Women who are pregnant or preparing to become pregnant or breast-feeding (10) Participants who are participating in other interventional clinical trials or have participated in other clinical trials within 12 weeks.

Design outcomes

Primary

MeasureTime frame
urinary albumin?to?creatinine ratio;urinary albumin excretion rates;

Secondary

MeasureTime frame
24-hour urinary protein quantification;Quality of life score;HbA1c;Blood biochemistry;TCM syndrome integral;

Countries

China

Contacts

Public ContactSun Weiwei

Dongzhimen Hospital Beijing University of Chinese Medicine

sunweitcm@163.com01080816655~8055

Outcome results

None listed

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