Exploring the Impact of Nephropathy Formula No. 1 on Chronic Kidney Disease Patients
Summary
This study is a prospective randomized controlled trial, enrolling 70 patients with CKD stages 2-4, randomly divided into a control group and a treatment group, with 35 cases in each group. The study subjects are sourced from three centers. The control group receives integrated basic treatment for chronic kidney disease, including dietary nutrition adjustment, blood pressure control, blood sugar control, lipid control, anemia treatment, and regulation of water, electrolyte, and acid-base metabolic balance. The treatment group, in addition to the basic treatment, is administered Nephropathy Formula No. 1 orally, with a treatment course of 12 weeks and a follow-up period of 2 weeks. The outcome measures are the changes in biochemical indicators, inflammatory factors, T cell subsets, STAT3 mRNA expression, and TCM syndrome scores after 12 weeks of treatment, to assess therapeutic efficacy. This study proposes the experimental hypothesis that Nephropathy Formula No. 1 can effectively improve the T cell immune balance in CKD patients by modulating the IL-6/STAT3 signaling pathway, thereby inhibiting the occurrence and development of renal fibrosis and improving the prognosis of CKD to a certain extent. Specifically, Nephropathy Formula No. 1 may function through the following mechanisms: (1) downregulating IL-6 mRNA expression, reducing IL-6 secretion, and thereby inhibiting the activation of the STAT3 signaling pathway; (2) regulating the balance of Th17/Treg cell subsets, promoting the differentiation of Th17 cells into Treg cells, enhancing the anti-inflammatory and immunosuppressive effects of Treg cells, and alleviating renal inflammatory responses and fibrosis. Through in-depth exploration of this study, it is expected to provide new ideas and methods for the clinical treatment of CKD, with significant scientific and clinical implications.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nephropathy Formula No. 1 | Unknown | 300 ml | Oral |
| Background | Amlodipine | Other / unclassified | 5 mg | — |
| Background | Atorvastatin | Small molecule | 20 mg | — |
| Background | Fenofibrate | Small molecule | 0.2 g | — |
| Background | Gliclazide | Small molecule | 30 mg | — |
| Background | Ketoacid | Unknown | 2.6 g | — |
| Background | Losartan | Other / unclassified | 100 mg | — |
| Background | Nifedipine | Other / unclassified | 30 mg | — |
| Background | Repaglinide | Small molecule | 1 mg | — |
| Background | epoetin alfa | Protein / enzyme biologic | 10000 iu | Subcutaneous |