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Based on the ''spleen-stomach-intestine-kidney'' axis, the evidence-based evaluation of the clinical efficacy of Qihuangyi kidney granules in the prevention and treatment of diabetic kidney disease and the study of biological mechanisms were discussed

Phase 3
Conditions
Diabetic kidney disease
Registration Number
ITMCTR2022000035
Lead Sponsor
Wangjing Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Meet the diagnostic criteria for diabetic kidney disease;
(2) Age 30 to 85 years old;
(3) Blood pressure = 150/90mmHg;
(4) Glycosylated hemoglobin = 8.5%;
(5) eGFR=25ml/min
(6) Sign the informed consent form and follow up on time.

Exclusion Criteria

(1) Blood pressure < 90/60mmHg;
(2) Blood creatinine doubled in the past six months;
(3) Unilateral or bilateral renal artery stenosis;
(4) Serious large vascular events have occurred in the past six months;
(5) Complicated by malignant tumors, hematologic diseases and other serious diseases;
(6) There is a serious psychological or mental abnormality;
(7) Pregnant or lactating women;
(8) Considering other renal diseases complicated by other kidney diseases (such as urinary tract infections, urinary sediment activity manifestations (red blood cells), etc.) that require renal puncture to confirm the diagnosis;
(9) Those who have undergone dialysis or kidney transplantation.
Note: Any of the above conditions will not be included.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
24-hour urine protein quantification;
Secondary Outcome Measures
NameTimeMethod
urea nitrogen;Estimated glomerular filtration rate;Urine microalbumin to creatinine ratio;Serum creatinine;TCM symptom score;metabolomics;Gut flora;
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