Exploring the Impact of Nephropathy Formula No. 1 on T-Cell Immune Balance in Chronic Kidney Disease Patients Via the IL-6/STAT3 Signaling Pathway
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- the ratio of Th17 to Treg cells in T cell subsets
Study Overview
Brief 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.
Detailed Description
Sample Size Estimation Sample size estimation is based on the results of a pilot study. A total of 60 patients are required for enrollment. Considering a dropout rate of 10%-15%, each group will need 35 cases, with a total of 70 cases for both groups.
Patient Recruitment Patients will be recruited by researchers during outpatient or inpatient visits. After screening according to the inclusion and exclusion criteria, eligible patients will be enrolled in the study following the signing of the informed consent form.
Adverse Events and Serious Adverse Events Management Severity: Physicians can use the following definitions to judge the severity of all adverse events and serious adverse events, which will serve as endpoints/data cutoff points for the study.
Mild: Adverse events are transient and easily tolerated by the patient. Moderate: Adverse events cause discomfort to the subject and interfere with their normal activities.
Severe: Adverse events significantly impact the subject's daily activities and may result in functional loss or be life-threatening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 65 years old (inclusive);
- •No gender restriction;
- •Patients diagnosed with CKD stages 2-4 according to the above diagnostic criteria by a specialist physician;
- •TCM syndrome differentiation is consistent;
- •Able to cooperate with the study treatment and follow-up, and has good compliance;
- •Agree and sign the medical informed consent form.
Exclusion Criteria
- •Patients undergoing hemodialysis or peritoneal dialysis;
- •Patients with severe primary diseases of the cardiovascular, hematological, digestive, nervous, respiratory, endocrine systems, malignant tumors, etc.;
- •Patients in the active phase of autoimmune system diseases;
- •Patients with chronic infectious diseases such as active viral hepatitis, HIV, or active tuberculosis;
- •Patients with recent acute infections, and non-infectious complications such as hypertension and anemia that have not been effectively controlled;
- •Patients who have taken traditional Chinese medicine related to nephropathy treatment within the past month;
- •Patients who have undergone surgery, trauma, major bleeding, or blood transfusion within the past three months, or have severe clinical infections, electrolyte disturbances, and acid-base imbalances that have not been effectively controlled;
- •Pregnant or breastfeeding women;
- •Patients with mental disorders or poor compliance who cannot cooperate;
- •Patients who have participated in other drug tests within the past three months or have not completed the effective drug washout period. -
Arms & Interventions
Treatment group
Integrated Basic Treatment for Chronic Kidney Disease (CKD) Can Utilize the Following ：α-Keto acid tablets (2.6 g tid) ；Antihypertensive drugs such as amlodipine tablets (5 mg qd), nifedipine tablets (30 mg qd), or losartan tablets (100 mg qd)；Medications such as repaglinide tablets (1.0 mg qd) or gliclazide modified-release tablets (30 mg qd) ；Medications such as atorvastatin calcium tablets (20 mg qd) or fenofibrate capsules (0.2 g qd)； Recombinant human erythropoietin (10000 u qw)； Composition and Preparation of Nephropathy Formula No. 1 includes: Bupleurum , Paeonia lactiflora Pall. , Scutellaria baicalensis Georgi , Pinellia ternata (Thunb.) Breit. , Smilax glabra Roxb. , Oldenlandia diffusa (Willd.) Roxb. , Rhus chinensis Mill. , and Poria cocos (Schw.) Wolf . The decoction is concentrated to 300 ml, with one dose per day, taken in two divided doses.The treatment period for the above regimen is 12 weeks.
Intervention: Nephropathy Formula No. 1 (Drug)
Treatment group
Integrated Basic Treatment for Chronic Kidney Disease (CKD) Can Utilize the Following ：α-Keto acid tablets (2.6 g tid) ；Antihypertensive drugs such as amlodipine tablets (5 mg qd), nifedipine tablets (30 mg qd), or losartan tablets (100 mg qd)；Medications such as repaglinide tablets (1.0 mg qd) or gliclazide modified-release tablets (30 mg qd) ；Medications such as atorvastatin calcium tablets (20 mg qd) or fenofibrate capsules (0.2 g qd)； Recombinant human erythropoietin (10000 u qw)； Composition and Preparation of Nephropathy Formula No. 1 includes: Bupleurum , Paeonia lactiflora Pall. , Scutellaria baicalensis Georgi , Pinellia ternata (Thunb.) Breit. , Smilax glabra Roxb. , Oldenlandia diffusa (Willd.) Roxb. , Rhus chinensis Mill. , and Poria cocos (Schw.) Wolf . The decoction is concentrated to 300 ml, with one dose per day, taken in two divided doses.The treatment period for the above regimen is 12 weeks.
Intervention: integrated basic treatment for chronic kidney disease (Drug)
Control Group
The control group will receive integrated basic treatment for chronic kidney disease, including: ① Nutritional diet with low salt, low fat, and low high-quality protein, with a protein intake of 0.6-0.8g/(kg·d), of which 50% comes from high-quality protein, and essential amino acids or α-keto acid preparations of 0.1-0.2g/(kg·d) are supplemented. ② Blood pressure control. ③ Blood sugar control. ④ Lipid control. ⑤ Anemia treatment. ⑥ Regulation of water, electrolyte, and acid-base metabolic balance.
Intervention: integrated basic treatment for chronic kidney disease (Drug)
Outcomes
Primary Outcomes
the ratio of Th17 to Treg cells in T cell subsets
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Liu Zhanghong
Deputy Chief physician of Traditional Chinese Medicine
The Third Affiliated hospital of Zhejiang Chinese Medical University