An interventional study of Zuogui Jiangtang Shuluo Formula and Mecobalamin in Diabetic Peripheral Neuropathy (DPN), sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes mellitus, affecting 35%-50% of diabetic patients. Its pathogenesis involves metabolic disorders induced by hyperglycemia and dyslipidemia, leading to irreversible damage to neurons and vascular endothelial cells. Distal symmetric polyneuropathy (DSPN) is the most representative form, characterized by distal pain, numbness, and sensory loss, which may progress to ulcers, gangrene, and even amputation in severe cases.
Current modern medical treatments for DPN primarily focus on nutritional nerve support, antioxidative stress, and microcirculation improvement, but these approaches are limited in variety and may carry side effects. Traditional Chinese Medicine (TCM) offers advantages including higher safety and diverse therapeutic options.
Based on long-term clinical observation, our research group proposes that the core pathogenesis of DPN is Qi-Yin deficiency with blood stasis obstructing collaterals. The treatment principle is to nourish Yin, supplement Qi, activate blood circulation, and unblock collaterals, with Zuogui Jiangtang Shuluo Formula (ZGJTSLF) as the primary prescription. Previous studies have shown that ZGJTSLF can improve TCSS scores and nerve conduction velocity in DPN patients compared with mecobalamin, but high-level evidence is still lacking.
This randomized, parallel-controlled trial aims to evaluate the clinical efficacy of ZGJTSLF in treating DPN, with TCSS score and nerve conduction velocity as primary outcomes. Metabolomics and lipidomics will be employed to compare metabolic profiles between healthy controls and DPN patients before and after ZGJTSLF treatment, aiming to identify potential biomarkers and explore the underlying mechanisms.
This study is a single-center, randomized, parallel-controlled trial. A total of 74 patients with DPN (37 per group) will be recruited from the outpatient and inpatient departments of Endocrinology at The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between August 2026 and August 2027, along with 30 healthy volunteers as controls.
This study is a single-center, randomized, parallel-controlled trial. It is prepared to recruit 74 patients with diabetic peripheral neuropathy (DPN) from the outpatient and inpatient departments of Endocrinology at The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between January 2026 and December 2026, along with 30 healthy volunteers as normal controls, based on clinical diagnostic criteria and screening criteria. Eligible DPN patients will be randomly assigned in a 1:1 ratio to either the Zuogui Jiangtang Shuluo Formula (ZGJTSLF) group or the mecobalamin control group using a random number generator in SPSS software with a fixed seed. This is an open-label trial for participants, care providers, and investigators; however, the outcomes assessor, specifically, the technician responsible for nerve conduction velocity measurements, will be blinded to group allocation. Patients in the ZGJTSLF group will receive Zuogui Jiangtang Shuluo Formula decoction, while those in the control group will receive mecobalamin tablets, both for 4 consecutive weeks. The primary outcomes include the Toronto Clinical Scoring System (TCSS) score and nerve conduction velocity (NCV), and secondary outcomes include TCM syndrome score, fasting plasma glucose, glycated hemoglobin, and lipid profile. Meanwhile, blood, urine, and fecal samples will be collected from all participants, including healthy volunteers, at baseline and after 4 weeks of treatment and frozen for further analysis. Plasma metabolomics and lipidomics profiling will be performed using UPLC-MS/MS technology to detect differential metabolites and lipids, analyze the differences among the groups, identify potential biomarkers, and explore the underlying mechanisms of ZGJTSLF in treating DPN. Correlation analysis between differential metabolites/lipids and clinical parameters will also be conducted. All statistical analyses will be performed using SPSS version 26.0, with a two-sided P \< 0.05 considered statistically significant. This study has been approved by the Ethics Committee of The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine (Approval No. HN-LL-YJSLW-2026), and all participants will provide written informed consent.
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DSPN inclusion criteria:
DSPN exclusion criteria
Healthy volunteer inclusion criteria:
Healthy volunteer exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive Zuogui Jiangtang Shuluo Formula for 4 consecutive weeks.
Drug: Zuogui Jiangtang Shuluo Formula
Participants in this arm will receive mecobalamin tablets for 4 consecutive weeks.
Drug: Mecobalamin
Oral decoction, twice daily for 4 weeks.
Also known as: Regular treatment
Tablet, 0.5 mg per dose, three times daily orally for 4 weeks.
Also known as: Regular treatment
Change in Nerve Conduction Velocity (NCV)
NCV measurements include motor nerve conduction velocity of the median, ulnar, tibial, and common peroneal nerves, and sensory nerve conduction velocity of the median and sural nerves.
Time frame: Baseline and 4 weeks after treatment completion
Change in Toronto Clinical Scoring System (TCSS) Score
The Toronto Clinical Scoring System (TCSS) assesses neuropathic symptoms, sensory function, and reflexes. Neuropathic symptoms include foot pain, numbness, tingling, and ataxia; each symptom is scored 1 if present and 0 if absent (maximum 4 points). Sensory function tests include light touch, pain, temperature, vibration, and position sense; each test is scored 1 if abnormal and 0 if normal (maximum 5 points). Reflexes include knee and ankle reflexes bilaterally; each reflex is scored 0 if normal, 1 if reduced, and 2 if absent (maximum 8 points). The total score ranges from 0 to 19, with higher scores indicating more severe neuropathy.
Time frame: Baseline and 4 weeks after treatment completion
Change in Traditional Chinese Medicine (TCM) Syndrome Score
The TCM syndrome score assesses primary and secondary symptoms according to the Guiding Principles for Clinical Research of New Traditional Chinese Medicines and the Clinical Diagnosis and Treatment Guidelines for Diabetic Peripheral Neuropathy in TCM (2016 Edition). Primary symptoms (limb weakness, limb pain and/or numbness) are graded as none, mild, moderate, or severe, scored 0, 2, 4, or 6, respectively (maximum 12 points). Secondary symptoms (fatigue, shortness of breath, spontaneous sweating, night sweating, feverish sensation in palms and soles, soreness and weakness of waist and knees, localized stabbing pain aggravated at night, dry and scaly skin, and purplish lips) are graded as none, mild, moderate, or severe, scored 0, 1, 2, or 3, respectively (maximum 18 points). The total score ranges from 0 to 30, with higher scores indicating more severe symptoms.
Time frame: Baseline and 4 weeks after treatment completion
Change in Fasting Blood Glucose (FBG)
Venous blood will be collected after at least 8 hours of fasting. Fasting blood glucose (FBG) will be measured using an automated biochemical analyzer, with the unit expressed as mmol/L.
Time frame: Baseline and 4 weeks after treatment completion
Change in Glycated Hemoglobin (HbA1c)
Fasting venous blood will be collected. Glycated hemoglobin (HbA1c) will be measured using high-performance liquid chromatography (HPLC) and expressed as a percentage (%), reflecting the average blood glucose level over the preceding 2-3 months.
Time frame: Baseline and 4 weeks after treatment completion
Change in DN4 Questionnaire Score
The DN4 (Douleur Neuropathique 4) questionnaire is a validated screening tool for neuropathic pain, consisting of 10 items (7 related to symptom description and 3 related to clinical examination). The total score ranges from 0 to 10, with a score ≥4 indicating the presence of neuropathic pain.
Time frame: Baseline and 4 weeks after treatment completion
Change in Visual Analog Scale (VAS) for Pain
The VAS consists of a 100-mm horizontal line, with the left end labeled "0" (no pain) and the right end labeled "100" (worst imaginable pain). Participants will mark the line according to their average pain intensity over the past 24 hours, and the distance in millimeters will be recorded as the pain score.
Time frame: Baseline and 4 weeks after treatment completion
Change in Lipid Profile
Venous blood will be collected after at least 8 hours of fasting. Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured using an automated biochemical analyzer. All parameters are expressed in mmol/L.
Time frame: Baseline and 4 weeks after treatment completion
Changes in Serum Untargeted Metabolomic Profiles
Fasting peripheral venous blood samples will be collected. Serum will be separated and stored at -80°C. Untargeted metabolomics analysis will be performed using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Raw data will be processed through peak extraction, alignment, and normalization, then imported into SIMCA software for multivariate statistical analysis. Principal Component Analysis and Orthogonal Partial Least Squares Discrimination Analysis will be used to distinguish metabolic profile differences among groups. Differential metabolites will be selected based on Variable Importance in Projection \> 1, P \< 0.05, and False Discovery Rate \< 0.1. The aim is to identify potential metabolic biomarkers associated with DPN and ZGJTSLF intervention.
Time frame: Baseline and 4 weeks after treatment completion
Changes in Serum Targeted Lipidomic Profiles
Fasting peripheral venous blood samples will be collected from all participants at baseline and after 4 weeks of treatment. Serum will be separated and stored at -80°C. Targeted lipidomics analysis will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS), covering major lipid classes including glycerophospholipids, sphingolipids, and glycerolipids. Lipid identification will be performed using the LIPIDBLAST database, and quantification will be conducted using MultiQuant software. Missing values will be estimated using the K-Nearest Neighbors algorithm, and data will be normalized using internal standards. Differential lipids will be identified by unpaired t-test with Benjamin-Hochberg adjustment; an adjusted P \< 0.05 will be considered statistically significant. The aim is to identify potential lipid biomarkers associated with DPN and ZGJTSLF intervention.
Time frame: Baseline and 4 weeks after treatment completion
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine