Evaluation of the Efficacy and Safety of Shenyan Siwei Pill in the Treatment of Chronic Kidney Disease Stages 1-3 (Spleen-Kidney Qi Deficiency with Blood Stasis Syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026001448

Enrollment

Unknown

Registered

2026-06-10

Start date

2026-06-22

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

Chronic Kidney Disease

Interventions

Experimental Group:Basic treatment + Shenyan Siwei Pill

Control Group:Basic treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75 years, any gender; (2) Diagnosed with chronic kidney disease (CKD stages 1-3); (3) TCM pattern of spleen-kidney qi deficiency with blood stasis; (4) Stable ARB treatment (e.g., valsartan 80mg/day) =1 month; pre-randomization BP: 100 = SBP <160 mmHg, 60 = DBP <100 mmHg; (5) 30 mg/g = UACR <5000 mg/g; (6) HbA1c =9%; (7) Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Allergy to investigational drug components; (2) Abnormal liver function (AST/ALT =3×ULN) or active hepatitis/cirrhosis; (3) Systemic lupus erythematosus or drug-induced nephropathy; (4) Type 1 diabetes; (5) Severe acute diabetic complications within 6 months (e.g., ketoacidosis, hyperosmolar coma); (6) LDL-C >3.5 mmol/L despite lipid-lowering therapy; (7) Serum potassium >5.5 mmol/L; (8) Current use of corticosteroids/immunosuppressants; (9) Acute coronary syndrome, heart failure (NYHA III-IV), stroke, or related surgeries within 1 year; (10) HIV infection; (11) Substance abuse history; (12) Pregnancy, lactation, or refusal of contraception; (13) Comorbidities interfering with assessments (psychiatric, immunological, endocrine disorders, malignancies); (14) Participation in other clinical trials within 3 months; (15) Investigator-determined ineligibility.

Design outcomes

Primary

Measure	Time frame
Estimated glomerular filtration rate (eGFR);	—

Secondary

Measure	Time frame
24-hour urine protein (g/24h), Urine albumin-to-creatinine ratio (UACR), Urea/Urea nitrogen (BUN), Serum creatinine (Scr);Urinary sediment abnormalities (red blood cells, red blood cell casts);Traditional Chinese Medicine (TCM) Syndrome Efficacy;TCM syndrome individual symptom scores;	—

Countries

China

Contacts

Public ContactHu Jing

Shanghai Seventh People's Hospital

6264570@qq.com13402121761

Outcome results

None listed

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