Clinical Study of Zuogui Jiangtang Shuluo Formula in Treating Diabetic Peripheral Neuropathy

This study is a single‐center, randomized, parallel‐controlled trial. A total of 74patients with DPN (37 per group) will be recruited from the outpatient and inpatientdepartments of Endocrinology at The First Affiliated Hospital of Hunan University ofTraditional Chinese Medicine between August 2026 and August 2027, along with 30 healthyvolunteers as controls.This study is a single‐center, randomized, parallel‐controlled trial. It is prepared torecruit 74 patients with diabetic peripheral neuropathy (DPN) from the outpatient andinpatient departments of Endocrinology at The First Affiliated Hospital of HunanUniversity of Traditional Chinese Medicine between January 2026 and December 2026, alongwith 30 healthy volunteers as normal controls, based on clinical diagnostic criteria andscreening criteria. Eligible DPN patients will be randomly assigned in a 1:1 ratio toeither the Zuogui Jiangtang Shuluo Formula (ZGJTSLF) group or the mecobalamin controlgroup using a random number generator in SPSS software with a fixed seed. This is anopen‐label trial for participants, care providers, and investigators; however, theoutcomes assessor, specifically, the technician responsible for nerve conduction velocitymeasurements, will be blinded to group allocation. Patients in the ZGJTSLF group willreceive Zuogui Jiangtang Shuluo Formula decoction, while those in the control group willreceive mecobalamin tablets, both for 4 consecutive weeks. The primary outcomes includethe Toronto Clinical Scoring System (TCSS) score and nerve conduction velocity (NCV), andsecondary outcomes include TCM syndrome score, fasting plasma glucose, glycatedhemoglobin, and lipid profile. Meanwhile, blood, urine, and fecal samples will becollected from all participants, including healthy volunteers, at baseline and after 4weeks of treatment and frozen for further analysis. Plasma metabolomics and lipidomicsprofiling will be performed using UPLC‐MS/MS technology to detect differentialmetabolites and lipids, analyze the differences among the groups, identify potentialbiomarkers, and explore the underlying mechanisms of ZGJTSLF in treating DPN. Correlationanalysis between differential metabolites/lipids and clinical parameters will also beconducted. All statistical analyses will be performed using SPSS version 26.0, with atwo‐sided P < 0.05 considered statistically significant. This study has been approved bythe Ethics Committee of The First Affiliated Hospital of Hunan University of TraditionalChinese Medicine (Approval No. HN‐LL‐YJSLW‐2026), and all participants will providewritten informed consent.