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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
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006734
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-02-20

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:Traditional Chinese medicinal granules
control group:Traditional Chinese medicinal placebo

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 diagnostic criteria of ckd3-4 of Western medicine; (2) Meet the TCM standards for qi deficiency and stasis; (3) Patients aged 18-75 years old, without gender limitation, and who have not received dialysis treatment; (4) Blood pressure = 140 / 90mmHg after basic hypotension; (5) The primary diseases are chronic glomerulonephritis, hypertension, diabetes, hepatitis B Related Nephritis and so on, and the disease is stable; (6) The patient agreed to the treatment of the study, joined the chronic disease management, and signed the informed consent; (7) No other drug tests have been conducted in the last 3 months or the effective drug elution period has passed

Exclusion criteria

Exclusion criteria: (1) Patients with acute infectious diseases and surgical and traumatic stress; (2) Patients with chronic infectious diseases, such as chronic hepatitis B in the active phase and delayed migration, cirrhosis in the decompensated phase or active tuberculosis; (3) Diseases with severe organ function damage affecting the survival of patients, such as malignant tumors and HIV infection; (4) Patients with serious primary diseases such as cardiovascular, blood system, digestive system and respiratory system; (5) Those who have a history of major bleeding or blood transfusion in the past 3 months, have signs of serious clinical infection and acidosis, complicated with hyperkalemia, heart failure and other life-threatening patients; (6) Severe allergic constitution, allergic or intolerable to certain drugs known in the study; (7) Pregnant or lactating patients; (8) Have a history of drug abuse; (9) Patients with primary polycystic kidney disease; (10) Patients who are participating in other clinical trials or who use other traditional Chinese medicine in the same period to affect the judgment of efficacy; (11) The fluctuation range of eGFR within 3 months before enrollment was = 30%; (12) Those who are ready for or have adopted renal transplantation, and those who have acute renal failure, chronic renal failure with acute exacerbation and need immediate replacement treatment; (13) Acute renal injury caused by post renal factors, such as obstruction (including renal calculi, urate crystals, tumors, etc.); (14) Patients with a history of psychosis or communication and cognitive impairment who have poor compliance and cannot cooperate.

Design outcomes

Primary

MeasureTime frame
serum creatinine;

Secondary

MeasureTime frame
protein-creatinine ratio;estimated glomerular filtration rate;

Countries

China

Contacts

Public ContactLu Keda

The First Affiliated Hospital of Zhejiang University of Chinese Medicine

lukedaq@126.com13757175879

Outcome results

None listed

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