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Adaptive Platform Clinical Study of Optimal Dosage of Tangshen Formula in Treating Diabetic Kidney Disease

Adaptive Platform Clinical Study of Optimal Dosage of Tangshen Formula in Treating Diabetic Kidney Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001423
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-07-09
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Diabetic Kidney Disease (DKD)

Interventions

Experimental Group 1: Low-dose Tangshen + Standard Western Treatment:Low-dose: 1 bag each time, three times daily
Experimental Group 2: Standard-dose Tangshen + Standard Western Treatment:Standard-dose: 2 bags each time, three times daily
Experimental Group 3: High-dose Tangshen + Standard Western Treatment:High-dose: 3 bags each time, three times daily

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 18-75, any gender 2) Confirmed diagnosis of type 2 diabetes with HbA1c =11% at screening 3) Meet DKD diagnostic criteria: eGFR (CKD-EPI) 25-75 mL/min/1.73m² with UACR =30 mg/g, or eGFR 25-3 months) 4) TCM pattern of Qi-Yin deficiency with blood stasis 5) Willing to sign informed consent and comply with follow-up

Exclusion criteria

Exclusion criteria: 1 Severe diabetic complications (e.g., ketoacidosis, hyperosmolar coma) or recent (=6 months) acute cardiovascular events (MI, unstable angina, stroke) 2) Active infections within 4 weeks 3) Current or recent (=4 weeks) use of other herbal treatments for DKD 4) Pregnancy, planned pregnancy, or lactation 5) Known allergy to Tangshen Formula components 6) Severe comorbidities: hematologic disorders, malignancies, NYHA Class III-IV heart failure, liver dysfunction (ALT/AST >2×ULN) 7) Uncontrolled hypertension (resting SBP =160 mmHg and/or DBP =100 mmHg) 8) Psychiatric disorders affecting compliance 9) Non-diabetic kidney disease (e.g., glomerulonephritis) 10) Hyperkalemia (serum K+ >5.5 mmol/L)

Design outcomes

Primary

MeasureTime frame
Estimated Glomerular Filtration Rate (eGFR);

Secondary

MeasureTime frame
Urinary albumin-to-creatinine ratio;glycosylated hemoglobin;

Countries

China

Contacts

Public ContactJiang Li

China-Japan Friendship Hospital

jiangli01@zryhyy.com.cn18811701807

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026