Diabetic Peripheral Neuropathy (DPN)NCT07771894
Clinical Study of Zuogui Jiangtang Shuluo Formula in Treating Diabetic Peripheral Neuropathy
A study testing Zuogui Jiangtang Shuluo Formula and Mecobalamin in people with Diabetic Peripheral Neuropathy (DPN), run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Zuogui Jiangtang Shuluo Formula and Mecobalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DSPN inclusion criteria:
- Meet the diagnostic criteria for type 2 diabetes mellitus with distal symmetric polyneuropathy (DSPN) according to Western medicine standards.
- Meet the TCM syndrome differentiation criteria for consumptive thirst complicated with arthromyodynia of the pattern of Qi-Yin deficiency with blood stasis.
- Glycated hemoglobin (HbA1c) between 6.5% and 9.0% (inclusive).
- Aged 35 to 75 years (inclusive) at the time of screening, regardless of gender.
- Have not participated in any other clinical trial within 2 weeks prior to the start of treatment, and have not taken lipid-lowering agents, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, immunosuppressants, or other traditional Chinese medicines that may affect metabolomic and lipidomic profiles.
- Willing to voluntarily participate in the trial and adhere to the 4-week traditional Chinese medicine treatment regimen.
- Right-handed.
- Provide written informed consent and are able to understand and comply with the study protocol requirements, including dietary and exercise recommendations and blood glucose monitoring.
DSPN exclusion criteria
- Patients with type 1 diabetes mellitus or other specific types of diabetes mellitus.
- Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.
- Neuropathies caused by other conditions, including but not limited to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, epilepsy, spinal cord injury, cervical or lumbar spine lesions (nerve root compression, spinal stenosis, cervical or lumbar degenerative diseases), neuromuscular diseases, severe arterial or venous vascular diseases (venous thrombosis, lymphangitis, etc.), sequelae of cerebrovascular disease, or post-surgical status of lower extremity vasculature.
- History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to study enrollment.
- History of acute diabetic complications (diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state) within 3 months prior to study enrollment.
- Concomitant severe complications of diabetes, such as end-stage diabetic kidney disease, or proliferative diabetic retinopathy.
- Concomitant severe diseases of the heart, liver, kidney, cerebrovascular system, or malignant tumors, defined as serum creatinine >200 μmol/L, blood urea nitrogen >1.5 times the upper limit of normal, or alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal.
- Any infection that, in the investigator's opinion, makes the patient unsuitable for participation prior to study enrollment, including but not limited to urinary tract infection, respiratory infection, or diabetic foot with infection requiring further treatment.
- Patients with psychiatric disorders, cognitive impairment, or inability to cooperate with the study procedures; or individuals with a history of alcohol abuse or drug addiction.
Healthy volunteer inclusion criteria:
- Aged 18 to 55 years (inclusive) at the time of screening, regardless of gender.
- Body mass index (BMI) within the range of 19.0 to 26.0 kg/m² (inclusive). No severe diseases of the heart, liver, kidney, cerebrovascular system, or malignant tumors; routine laboratory tests, electrocardiogram, and chest X-ray are essentially within normal limits.
- Have not participated in any other clinical trial within 2 weeks prior to the start of treatment, and have not taken lipid-lowering agents, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, immunosuppressants, or other traditional Chinese medicines that may affect metabolomic and lipidomic profiles.
- Voluntarily sign the informed consent form and are willing and able to cooperate with the investigators to complete the clinical study.
Healthy volunteer exclusion criteria:
- Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.
- Patients with psychiatric disorders, cognitive impairment, or inability to cooperate with the study procedures.
- Individuals with a history of alcohol abuse or drug addiction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410000
The First Affiliated Hospital of Hunan University of Tradition, 0731-85600565
About this study
Official title: Mechanistic Study of Zuogui Jiangtang Shuluo Formula in Regulating Lipid Metabolism and Inhibiting Ferroptosis for the Prevention and Treatment of Diabetic Peripheral Neuropathy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- Zuogui Jiangtang Shuluo Formula, Mecobalamin
- Keywords
- Diabetic Peripheral Neuropathy, Zuogui Jiangtang Shuluo Formula, DPN, Metabolomics, Lipidomics, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zuogui Jiangtang Shuluo FormulaDrug
Also called Regular treatment
Oral decoction, twice daily for 4 weeks.
MecobalaminDrug
Also called Regular treatment
Tablet, 0.5 mg per dose, three times daily orally for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Zuogui Jiangtang Shuluo Formula Group | Experimental | Participants in this arm will receive Zuogui Jiangtang Shuluo Formula for 4 consecutive weeks. Receives: Drug: Zuogui Jiangtang Shuluo Formula |
| Mecobalamin Control Group | Active comparator | Participants in this arm will receive mecobalamin tablets for 4 consecutive weeks. Receives: Drug: Mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks after treatment completion
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Yu, Study director, The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineJuan Huang, Principal investigator, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771894
- Sponsor's protocol ID
- HN-LL-YJSLW-2026-06
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study of Zuogui Jiangtang Shuluo Formula in Regulating Lipid Metabolism and Inhibiting Ferroptosis for the Prevention and Treatment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07771894
- Acronym / sponsor ID
- HN-LL-YJSLW-2026-06
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic Peripheral Neuropathy, Zuogui Jiangtang Shuluo Formula, DPN, Metabolomics, Lipidomics, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zuogui Jiangtang Shuluo Formula Group | Experimental | Drug: Zuogui Jiangtang Shuluo FormulaParticipants in this arm will receive Zuogui Jiangtang Shuluo Formula for 4 consecutive weeks. |
| Mecobalamin Control Group | Active comparator | Drug: MecobalaminParticipants in this arm will receive mecobalamin tablets for 4 consecutive weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zuogui Jiangtang Shuluo FormulaAlso: Regular treatmentOral decoction, twice daily for 4 weeks. | Drug | Zuogui Jiangtang Shuluo Formula Group |
| MecobalaminAlso: Regular treatmentTablet, 0.5 mg per dose, three times daily orally for 4 weeks. | Drug | Mecobalamin Control Group |
Primary outcome
Change in Nerve Conduction Velocity (NCV)
Time frame: Baseline and 4 weeks after treatment completion
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.
Change in Toronto Clinical Scoring System (TCSS) Score
Time frame: Baseline and 4 weeks after treatment completion
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.
Change in Traditional Chinese Medicine (TCM) Syndrome Score
Time frame: Baseline and 4 weeks after treatment completion
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.
7 secondary outcomes
Change in Fasting Blood Glucose (FBG)
Time frame: Baseline and 4 weeks after treatment completion
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 4 weeks after treatment completion
Change in DN4 Questionnaire Score
Time frame: Baseline and 4 weeks after treatment completion
Change in Visual Analog Scale (VAS) for Pain
Time frame: Baseline and 4 weeks after treatment completion
Change in Lipid Profile
Time frame: Baseline and 4 weeks after treatment completion
Changes in Serum Untargeted Metabolomic Profiles
Time frame: Baseline and 4 weeks after treatment completion
Changes in Serum Targeted Lipidomic Profiles
Time frame: Baseline and 4 weeks after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Yu study director
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Juan Huang principal investigator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zuogui Jiangtang Shuluo Formula and Mecobalamin in people with Diabetic Peripheral Neuropathy (DPN), run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Tao, Doctor (+8618874811564, 1376027775@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nerve Conduction Velocity (NCV) (time frame: Baseline and 4 weeks after treatment completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.