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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
ChiCTR
Registry ID
ChiCTR2600126263
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-24
Completion date
Unknown
Last updated
2026-06-08

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

Trial Group 1: Low-dose Tangshen + Standard Western Treatment:Low-dose: 1 bag each time, three times daily
Trial Group 2: Standard-dose Tangshen + Standard Western Treatment:Standard-dose: 2 bags each time, three times daily
Trial 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: 1. Age 18-75, any gender; 2. Confirmed diagnosis of type 2 diabetes with HbA1c =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 (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
Change from baseline in estimated glomerular filtration rate (eGFR);

Secondary

MeasureTime frame
Change from baseline in urinary albumin-to-creatinine ratio (UACR);Change from baseline in body weight, waist circumference, blood pressure, lipid profile, and glycated hemoglobin at Week 24;Change from baseline in traditional Chinese medicine syndrome score;Change from baseline in health-related quality of life (HRQoL) score;

Countries

China

Contacts

Public ContactJiang Li

China-Japan friendship hospital

jiangli01@zryhyy.com.cn+86 188 1170 1807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026