Exploring the Impact of Nephropathy Formula No. 1 on Chronic Kidney Disease Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Nephropathy Formula No. 1: On the basis of integrated treatment for chronic kidney disease (the specific plan is the same as the control group), Nephropathy Formula No. 1 is given orally. The composition and decoction method of the formula are as follows: Bupleurum, Paeonia lactiflora Pall. , Scutellaria baicalensis Georgi , Pinellia ternata (Thunb.) Breit. , Smilax glabra Roxb. , Oldenlandia diffusa (Willd.) Roxb. , Tussilago farfara L. , Poria cocos (Schw.) Wolf , decocted into 300ml, one dose per day, taken warm in two divided doses for 12 weeks.

integrated basic treatment for chronic kidney disease: The integrated basic treatment for CKD includes the following: Dietary Nutrition: α-Keto acid tablets (2.6 g tid) may be used. Blood Pressure Control: Antihypertensive drugs such as amlodipine tablets (5 mg qd), nifedipine tablets (30 mg qd), or losartan tablets (100 mg qd) can be selected. β-blockers or α-blockers may be used in combination if necessary. Blood Sugar Control: Medications such as repaglinide tablets (1.0 mg qd) or gliclazide modified-release tablets (30 mg qd) can be used. Lipid Control: Medications such as atorvastatin calcium tablets (20 mg qd) or fenofibrate capsules (0.2 g qd) can be used. Anemia Treatment: Recombinant human erythropoietin (10000 u qw) can be administered via subcutaneous injection. Regulation of Water, Electrolyte, and Acid-Base Metabolic Balance.

Study 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.

Eligibility

Primary outcome measure(s)

• the ratio of Th17 to Treg cells in T cell subsets — 12 weeks
  The ratio of Th17 to Treg cells in peripheral blood will be measured using flow cytometry. The Th17/Treg ratio will be compared before and after treatment to determine the experimental outcomes.

Trial sites (3)

Other trials for the same condition