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

2026年8月14日 更新者：The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

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.

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

74

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Wang Tao, Doctor
  • 電話番号：+8618874811564
  • メール：1376027775@qq.com

研究連絡先のバックアップ

  • 名前：Xuerong Wu, Doctor
  • 電話番号：+8618274563501
  • メール：1021595345@qq.com

研究場所

  • 中国
    • Hunan
      • Changsha、Hunan、中国、410000
        • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
        • コンタクト：
          • The First Affiliated Hospital of Hunan University of Tradition
          • 電話番号：0731-85600565

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

DSPN inclusion criteria:

  1. Meet the diagnostic criteria for type 2 diabetes mellitus with distal symmetric polyneuropathy (DSPN) according to Western medicine standards.
  2. Meet the TCM syndrome differentiation criteria for consumptive thirst complicated with arthromyodynia of the pattern of Qi-Yin deficiency with blood stasis.
  3. Glycated hemoglobin (HbA1c) between 6.5% and 9.0% (inclusive).
  4. Aged 35 to 75 years (inclusive) at the time of screening, regardless of gender.
  5. 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.
  6. Willing to voluntarily participate in the trial and adhere to the 4-week traditional Chinese medicine treatment regimen.
  7. Right-handed.
  8. 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

  1. Patients with type 1 diabetes mellitus or other specific types of diabetes mellitus.
  2. Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.
  3. 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.
  4. History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to study enrollment.
  5. History of acute diabetic complications (diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state) within 3 months prior to study enrollment.
  6. Concomitant severe complications of diabetes, such as end-stage diabetic kidney disease, or proliferative diabetic retinopathy.
  7. 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.
  8. 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.
  9. 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:

  1. Aged 18 to 55 years (inclusive) at the time of screening, regardless of gender.
  2. 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.
  3. 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.
  4. 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:

  1. Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.
  2. Patients with psychiatric disorders, cognitive impairment, or inability to cooperate with the study procedures.
  3. Individuals with a history of alcohol abuse or drug addiction.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Zuogui Jiangtang Shuluo Formula Group
Participants in this arm will receive Zuogui Jiangtang Shuluo Formula for 4 consecutive weeks.
薬：Zuogui Jiangtang Shuluo Formula
Oral decoction, twice daily for 4 weeks.
他の名前：
  • Regular treatment
アクティブコンパレータ：Mecobalamin Control Group
Participants in this arm will receive mecobalamin tablets for 4 consecutive weeks.
薬：Mecobalamin
Tablet, 0.5 mg per dose, three times daily orally for 4 weeks.
他の名前：
  • Regular treatment

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Nerve Conduction Velocity (NCV)
時間枠：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.
Baseline and 4 weeks after treatment completion
Change in Toronto Clinical Scoring System (TCSS) Score
時間枠：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.
Baseline and 4 weeks after treatment completion
Change in Traditional Chinese Medicine (TCM) Syndrome Score
時間枠：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.
Baseline and 4 weeks after treatment completion

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Fasting Blood Glucose (FBG)
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Change in Glycated Hemoglobin (HbA1c)
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Change in DN4 Questionnaire Score
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Change in Visual Analog Scale (VAS) for Pain
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Change in Lipid Profile
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Changes in Serum Untargeted Metabolomic Profiles
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion
Changes in Serum Targeted Lipidomic Profiles
時間枠：Baseline and 4 weeks after treatment completion
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.
Baseline and 4 weeks after treatment completion

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

捜査官

  • スタディディレクター：Rong Yu、The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • 主任研究者：Juan Huang、The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月15日

一次修了 (推定)

2027年8月15日

研究の完了 (推定)

2027年9月15日

試験登録日

最初に提出

2026年8月10日

QC基準を満たした最初の提出物

2026年8月14日

最初の投稿 (実際)

2026年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HN-LL-YJSLW-2026-06

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