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Based on the clinical research platform of traditional Chinese medicine (TCM) the evidence-based study on the prevention and treatment of rapidly progressive diabetic kidney disease (DKD) by optimizing the scheme ofTonifying kidney filling qi dredging collaterals and eliminating symptoms

Based on the clinical research platform of traditional Chinese medicine (TCM) the evidence-based study on the prevention and treatment of rapidly progressive diabetic kidney disease (DKD) by optimizing the scheme ofTonifying kidney filling qi dredging collaterals and eliminating symptoms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000242
Enrollment
Unknown
Registered
2025-02-12
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Diabetic Kidney Disease

Interventions

Syndrome differentiation scheme group:Qiditangshen decoction and dialectical flavored\Western medicine standard treatment

Sponsors

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Age between 18 and 80 years old regardless of gender ; 2: Conform to the diagnostic criteria of diabetic kidney disease ( DKD ) ; the diagnostic criteria of diabetes mellitus ( DM ) refer to the ' Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes ( 2020 Edition ) '. The diagnostic criteria of DKD refer to the ' Guidelines for the Prevention and Treatment of Diabetic Kidney Disease in China ( 2021 Edition ) ' : the history of diabetes is also causally related to urinary protein and renal function changes and excludes other primary and secondary glomerular diseases and systemic diseases. DKD can be diagnosed if one of the following conditions is met. 1 Excluding the interference factors at least 2 times of urine microalbumin / urine creatinine ( UACR ) = 30mg / g or UACR = 30mg / 24h ( = 20ug / min ) in 3-6 months. Estimated glomerular filtration rate ( eGFR ) < 60ml / ( min · 1.73m2 ) lasted for more than 3 months. 3 Renal biopsy was consistent with the pathological diagnosis of

Exclusion criteria

Exclusion criteria: 1: Clearly diagnosed patients with primary glomerular disease occulted nephritis autoimmune disease and connective tissue disease blood disease tumor drug-induced renal damage and bilateral renal artery stenosis; 2: 24-hour urinary protein quantity > 3.5g /24h; 3: Patients with acute complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemia coma within 6 months; 4: Patients with severe respiratory digestive blood system and other primary diseases heart failure patients with reduced ejection fraction (LVEF=40%). Patients currently under stress with severe infection trauma major surgery acute coronary syndrome acute heart failure uncontrolled malignant arrhythmia and other emergencies; 5: Pregnancy lactation family planning; 6: Active hepatitis and liver function impairment (alanine aminotransferase aspartate aminotransferase greater than 2 times the upper limit of normal); 7: Type 1 diabetes mellitus and specific type diabetes mellitus; 8: Poor bloo

Design outcomes

Primary

MeasureTime frame
Progression rate;Events related to proteinuria;Renal composite endpoint events;

Secondary

MeasureTime frame
UACR slope;lipid profile;Renal function;blood glucose;Traditional Chinese medicine syndrome scores;Glomerular filtration rate slope;

Countries

China

Contacts

Public ContactHongfang Liu

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

lhfdoctor@126.com010-84013252

Outcome results

None listed

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