Stage 3-4 Chronic Kidney Disease
Conditions
Interventions
Treatment:Conventional Therapy + Haikun Shenxi Capsules
Control:Conventional Therapy + 5% Dose of Haikun Shenxi Capsules
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Age 18-70 years any gender; (2)Meeting diagnostic criteria for both: Western medicine criteria (2002 KDOQI CKD Guidelines) and Traditional Chinese Medicine (TCM) syndrome differentiation criteria; (3)Controlled comorbidities: Active infection resolved blood pressure =140/90 mmHg and so on; (4)Signed informed consent form Diagnostic Standards Western Medicine Criteria (Per 2002 NKF-KDOQI Clinical Practice Guidelines) Definition: Kidney structural/functional abnormalities =3 months with or without reduced GFR manifested by: Pathological abnormalities on renal biopsy or Markers of kidney damage (blood/urine abnormalities or imaging findings) or GFR 0.9mg/dL; female GFR=144×(Scr/0.7)-0.329×(0.993)age Scr=0.7mg/dL female GFR=144×(Scr/0.7)-1.209×(0.993)age Scr>0.7mg/dL Staging: G3a: GFR 45-59 mL/min/1.73m²; G3b: GFR 30-44 mL/min/1.73m²; G4: GFR 15-29 mL/min/1.73m² TCM Syndrome Differentiation Criteria (Per "TCM Guidelines for Chronic Renal Failure" & "Clinical Research Guiding Principles for New TCM Drugs") Damp-Turbidity Syndrome : Primary Symptoms: Nausea/vomiting Heavy limbs Edema; Secondary Symptoms: Abdominal distension Viscid sensation in mouth Thick greasy tongue coating (Diagnosis: =2 primary symptoms OR 1 primary + 2 secondary symptoms) Blood-Stasis Syndrome: Primary Symptoms: Dull complexion Lumbar pain; Secondary Symptoms: Squamous and dry skin Limb numbness Purple-dark tongue with ecchymosis Rough or fine-rough pulse (Diagnosis: =2 primary symptoms OR 1 primary + 2 secondary symptoms)
Exclusion criteria
Exclusion criteria: (1) Acute kidney injury (per KDIGO criteria); (2) Secondary kidney diseases including diabetic kidney disease hypertensive nephropathy IgA vasculitis nephritis (Henoch-Schönlein purpura nephritis) or lupus nephritis; (3) Severe primary disorders of cardiac (NYHA Class III-IV) cerebral (stroke 4 weeks GI surgery <3 months); (11) Other conditions compromising trial safety/data integrity per investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated Glomerular Filtration Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Routine Examination;Serum Albumin;Electrocardiogram;High-Sensitivity C-Reactive Protein;Blood Urea Nitrogen;Serum Uric Acid;TCM Syndrome Indicators;General Physical Examination;Urinalysis;24-hour Urine Protein Quantification;Liver Function (Alanine Transaminase Aspartate Transaminase);Serum Total Protein;Complete Blood Count;Triglyceride;Low-Density Lipoprotein;Electrolytes;Urinary Albumin-to-Creatinine Ratio;Fibrinogen;High-Density Lipoprotein;Serum Creatinine;Total Cholesterol; | — |
Countries
China
Contacts
Public ContactBo Yang
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed