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Clinical study of "Baoyuan Paidu pill" on the protection of renal tubules in patients with chronic kidney disease in stage 3-4 based on metabolomics

Clinical study of "Baoyuan Paidu pill" on the protection of renal tubules in patients with chronic kidney disease in stage 3-4 based on metabolomics

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072301
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-06-10
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

chronic kidney disease

Interventions

Control group:Basic treatment
Traditional Chinese Medicine Treat Group:Baoyuanpaidu dection+ basic treatment

Sponsors

Changzhou Hospital of traditional Chinese Medicine Affiliated to Nanjing University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria of stage CKD3-4, without renal replacement therapy, and meeting the criteria of TCM syndrome differentiation; 2. Between the ages of 18 and 75, regardless of gender; 3. When enrolled, blood pressure was controlled to be < 140/90mmHg, blood potassium < 5.5mmol/L, hemoglobin =80g/L, no acute infection, and the condition was stable for more than 2 weeks 4. Informed consent, voluntary subjects, the process of obtaining informed consent should comply with the provisions of GCP.

Exclusion criteria

Exclusion criteria: 1.Combined with serious primary diseases such as heart, brain, lung, liver and hematopoietic system; 2.24-hour urinary protein >2.0g/d; 3.Acute renal failure; 4.After renal transplantation; 5.History of mental illness; 6. Women who are pregnant or preparing to be pregnant or lactating; 7.Patients with known allergy to the drug used; 8.Persons under the age of 18 or over 65 years old; 9.Those who are participating in other clinical trials; 10.Patients who have been treated with western medicine glucocorticoids and immunosuppressants; 11.Blood routine examination showed hemoglobin <8g/L.

Design outcomes

Primary

MeasureTime frame
Serum creatinine;

Secondary

MeasureTime frame
Blood urea nitrogen;Cystatin C;Blood uric acid;Estimate the glomerular filtration rate;24-hour urine protein quantification;Parathyroid Hormone;Blood lipids;Metabolome;

Countries

China

Contacts

Public ContactShenju Wang

Changzhou Hospital of traditional Chinese Medicine Affiliated to Nanjing University of traditional Chinese Medicine

shenjuwang@163.com+86 138 1502 5618

Outcome results

None listed

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