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

NCT06796660 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2024ZL081
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• the ratio of Th17 to Treg cells in T cell subsets

  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.

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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.

Drug: Nephropathy Formula No. 1; Drug: integrated basic treatment for chronic kidney disease

Control Group

ACTIVE COMPARATOR

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.

Drug: integrated basic treatment for chronic kidney disease

Interventions

Nephropathy Formula No. 1 DRUG

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.

Also known as: Administration group

Treatment group

integrated basic treatment for chronic kidney disease DRUG

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.

Also known as: control group

Control Group; Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Liu Zhanghong: lead

Study Sites (3)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Wenzhou TCM Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Wenzhou TCM Hospital of Zhejiang Chinese Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhanghong Z Liu, Master

  The Third Afffliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanghong Z Liu, Master

CONTACT

+8613777770866; red_lzh@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief physician of Traditional Chinese Medicine

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)