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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000035
Enrollment
Unknown
Registered
2022-06-22
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Diabetic kidney disease

Interventions

Experimental group:Qihuang Yishen Granules
control group:Qihuang Yishen Granules Mimic

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;

Secondary

MeasureTime frame
urea nitrogen;Estimated glomerular filtration rate;Urine microalbumin to creatinine ratio;Serum creatinine;TCM symptom score;metabolomics;Gut flora;

Countries

China

Contacts

Public ContactLiu Shiwei
Liushiwei1977@126.com13810753021

Outcome results

None listed

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