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Clinical study of Gushenxizhuo prescription for the treatment of chronic kidney disease (spleen and kidney qi deficiency and damp turbid syndrome) and discussion of the mechanism of action based on metabolomics

Clinical study of Gushenxizhuo prescription for the treatment of chronic kidney disease (spleen and kidney qi deficiency and damp turbid syndrome) and discussion of the mechanism of action based on metabolomics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001362
Enrollment
Unknown
Registered
2025-07-09
Start date
2024-10-12
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Chronic kidney disease

Interventions

Conventional treatment group:Western medicine conventional treatment
Shen Shuai Ning Capsule Group:Shen Shuai Ning Capsules, taken orally, three times a day, 4 to 6 capsules each time.
Consolidating Kidney and Purging Turbidity Formula Group (Gushenxiezhufang Group):Gushenxiezhufang, taken orally, 1 dose per day. Decocted to obtain 300 mL of liquid, 150 mL per administration, twice

Sponsors

Tianjin University of Traditional Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Ages 18-80 years old; (2) Comply with CKD Western medicine diagnostic standards and staging standards; (3) Traditional Chinese medicine syndrome is consistent with spleen and kidney qi deficiency and dampness and turbidity; (4) The informed consent process complies with the regulations and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Secondary kidney disease caused by diabetes rheumatoid immune diseases hepatitis B virus etc.; (2) Accompanied by consciousness disorders acute infections severe heart liver lung and gastrointestinal dysfunction severe malnutrition etc.; (3) Malignant tumors primary bone metabolism diseases primary parathyroid diseases; (4) Acute renal injury caused by various reasons; (5) Receive parathyroid surgery and renal transplantation; (6) If you have mental illness you cannot cooperate breastfeeding or pregnancy; (7) Patients taking hormones and immunosuppressants; (8) Those who are allergic to test drugs and their excipients; (9) Those who participated in other clinical trials within 30 days before screening; (10) The researchers judged that it is not appropriate to be selected for this test.

Design outcomes

Primary

MeasureTime frame
urinary protein excretion;Glomerular filtration rate;TCM Symptom Score;

Secondary

MeasureTime frame
ß2-Microglobulin;Cystatin C;

Countries

China

Contacts

Public ContactGe Tang

Tianjin University of Traditional Chinese Medicine First Affiliated Hospital

tangge@tjutcm.edu.cn17320023673

Outcome results

None listed

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