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The Efficacy of Xiaoyu Xiezhuo Decoction on Chronic Kidney Disease in Stage 3-4: a Multicenter Clinical Study

The Efficacy of Xiaoyu Xiezhuo Decoction on Chronic Kidney Disease in Stage 3-4: a Multicenter Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045814
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Chronic Kidney Disease

Interventions

Sponsors

Zhejiang Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the Western medicine CKD 3-4 diagnostic criteria; 2. Meet the standard of Qi deficiency and blood stasis syndrome in TCM; 3. Those who are 18 to 75 years old, have no gender limit, and have not yet received dialysis treatment; 4. After basic blood pressure reduction, blood pressure 100g/L, no serious acidosis occurred; 6.24h urine protein quantification (24hUpr) <= 2.5g (at least two consecutive determinations, take the average); 7. The primary disease is chronic glomerulonephritis, hypertension, diabetes, hepatitis B-related nephritis, etc., and the condition is stable; 8. The patient agrees to the treatment of this study, joins the chronic disease management, and signs an informed consent form; 9. No other drug test has been performed in the past 3 months or the effective drug wash-out period has passed.

Exclusion criteria

Exclusion criteria: 1. Being treated with hormones, non-steroidal anti-inflammatory drugs or immunosuppressive agents; 2. Severe arrhythmia, acute heart failure, myocardial infarction, acute stroke, unstable angina, NYHA classification IV (New York Heart Association Heart Function Classification Standard); 3. Patients with acute infectious diseases, surgery and traumatic stress; patients with chronic infectious diseases such as chronic hepatitis B active and prolonged, decompensated liver cirrhosis, or active tuberculosis; 4. Diseases that are accompanied by severe organ damage that affect the survival of patients, such as malignant tumors, HIV infection, etc.; 5. Patients with severe primary diseases such as cardiovascular, blood system, nervous system, digestive system, respiratory system, etc., and those with obvious bleeding tendency; 6. Complicated with hyperkalemia, heart failure and other life-threatening persons; 7. GFR fluctuation range >= 30% within 3 months before enrollment; 8. Severe allergies, allergic or intolerant to certain drugs known in the study; 9. Patients during pregnancy or lactation; 10. Those who have had a history of hemorrhage or blood transfusion in the past 3 months, and have signs of serious clinical infection or acidosis; 11. Patients who have a history of mental illness or communication and cognitive dysfunction and other poor compliance who cannot cooperate; 12. Non-yellow race.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate;

Secondary

MeasureTime frame
protein-creatinine ratio;serum creatinine;blood urea nitrogen;end point events incidence;TCM syndrome integral;

Countries

China

Contacts

Public ContactLu Keda

The First Affiliated Hospital of Zhejiang University of Chinese Medicine

lukedaq@126.com+86 13757175879

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026