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A multi-center, randomized, controlled, double-blind clinical study on the treatment of Chronic kidney disease with Kidney-Yang deficiency syndrome by Wenshenyang prescription

A multi-center, randomized, controlled, double-blind clinical study on the treatment of Chronic kidney disease with Kidney-Yang deficiency syndrome by Wenshenyang prescription

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004410
Enrollment
Unknown
Registered
2020-11-04
Start date
2020-11-02
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:Prescription for warming kidney Yang combined with standardized western medications
control group:Placebo for warming shenyang with standardized western medications

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate in the clinical trial and sign the informed consent; 2. Subjects meeting the diagnostic criteria of chronic kidney disease; 3. Patients with nephrotic syndrome, chronic nephritis syndrome, diabetic nephropathy, IgA nephropathy, membranous nephropathy, focal segmental sclerosing glomerulonephritis, etc; 4. EGFR > 29ml / (min · 1.73m2) in patients with chronic kidney disease (CKD) stage 1-3; 5. Patients with kidney yang deficiency syndrome in TCM; 6. Patients aged 18-75 years old, regardless of gender.

Exclusion criteria

Exclusion criteria: 1. Patients with acute kidney injury in recent one month; 2. Patients with acute infectious diseases, active or delayed chronic hepatitis B, decompensated cirrhosis and active tuberculosis; 3. Patients with serious cardiovascular and cerebrovascular diseases, lung and liver diseases and other primary diseases, or mental diseases; 4. Patients with unstable vital signs and severe electrolyte disorder, or have received renal replacement therapy; 5. Patients with active gastrointestinal bleeding, severe thrombocytopenia, coagulation dysfunction and other hematological diseases in recent 3 months; 6. Patients with other diseases requiring long-term use of other traditional Chinese medicine preparations for more than 4 weeks; 7. Those patients whose aspartate aminotransferase and alanine aminotransferase are 1.5 times higher than the normal value; 8. Pregnant women, lactating women or women with pregnancy plans in the near future; 9. Those subjects with allergic constitution are known or suspected to be allergic to the test drug and its excipients; 10. Subjects who have participated in or are participating in other clinical trials in recent 3 months; 11. Subjects considered unsuitable by the researchers to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Twenty-four hours urinary protein content;urine albumin-creatinine ratio;TCM syndrome Rating Scale;Glomerular filtration rate;Serum creatinine;

Secondary

MeasureTime frame
albumin;Blood uric acid;hemoglobin;total protein;Blood urea nitrogen;

Countries

China

Contacts

Public ContactZongjiang Zhao

Beijing University of Chinese Medicine

zongjiangz@sina.com+86 13910507288

Outcome results

None listed

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