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A multi-center clinical study on the adaptability of Tangshen Formula in the treatment of diabetic nephropathy under the guidance of enrichment strategy

A multi-center clinical study on the adaptability of Tangshen Formula in the treatment of diabetic nephropathy under the guidance of enrichment strategy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000682
Enrollment
Unknown
Registered
2026-03-23
Start date
2025-05-30
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Diabetic Nephropathy

Interventions

control group:basic treatment
treatment group:Basic treatment + Qijian Granules

Sponsors

China-japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Age: 18-75 years old, gender not limited; 2) Clearly diagnosed type 2 diabetes; Glycated hemoglobin =11%; 3) Diabetic kidney disease: eGFR: 25-75ml/min/(1.73m2) with UACR=30mg/g, or eGFR: 25 - <60 ml/min/(1.73m2) and UACR<30mg/g; And it has lasted for more than three months; 4) According to traditional Chinese medicine diagnosis, it is a syndrome of deficiency of both qi and Yin with blood stasis. 5) Sign informed consent and be able to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1) Those with severe diabetes and those who have experienced major vascular events within half a year; 2) There are various infected individuals within 4 weeks; 3) Other traditional Chinese medicines for treating diabetic kidney diseases; 4) Pregnant or lactating women, and those who are allergic to the test drug; 5) Combined with other serious diseases, such as hematological diseases, malignant tumors, severe heart failure, and obvious liver diseases; 6) Uncontrolled hypertension (SBP=160mmHg and/or DBP=100 mmHg); 7) Patients with mental illness or those who are unable to follow along; 8) Kidney diseases that have been clearly identified as not caused by diabetes; 9) Hyperkalemia (blood potassium > 5.5mmol/L).

Design outcomes

Primary

MeasureTime frame
glomerular filtration rate;

Secondary

MeasureTime frame
Urinary albumin-to-creatinine ratio;24-hour urine protein quantification;weight;waistline;blood pressure;blood fat;FBG;glycosylated hemoglobin;syndrome of Chinese medicine;quality of life;

Countries

China

Contacts

Public ContactWU XIAI

China-japan Friendship Hospital, Chaoyang District, Beijing

13810264909@126.com13810264909

Outcome results

None listed

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