Diabetic peripheral neuropathy
Conditions
Interventions
test group:Basic treatment of diabetes peripheral neuropathy: The basic treatment is formulated according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)
Sponsors
Tsinghua University Yuquan Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion Criteria for DPN Participants in the Clinical Trial Section: (1) Meet the clinical diagnosis of diabetic peripheral neuropathy and have a clinical confirmation; (2) Meet the TCM syndrome diagnosis of qi deficiency and blood stasis for diabetic peripheral neuropathy; (3) Toronto score =6; (4) Aged between 45 and 75 years old, with no gender restrictions; (5) Have received basic diabetes treatment and have stable blood sugar control (fasting blood glucose: <7mmo/L; 2-hour postprandial blood glucose: <11.1mmol/L; HbA1c: <8%); (6) Not taken or stopped taking drugs associated with DPN for more than one week; (7) Right-handed; (8) Signed the informed consent form. 2.Inclusion Criteria for DPN Participants in the functional Magnetic Resonance Imaging (fMRI) Study Section: The same as the inclusion criteria for DPN participants in the clinical trial section. 3.Inclusion Criteria for Healthy Individuals in the fMRI Study Section: (1) Aged between 45 and 75 years old, with no gender restrictions; (2) No history of diabetes; (3) In good physical condition during the trial period, with no discomfort or organic or severe functional diseases; (4) Right-handed; (5) Not participating in any other clinical trials; (6) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for DPN Participants in the Clinical Trial Section: (1) Participants with diabetic ketoacidosis, ketoacidosis acidosis, or concurrent infections; (2) Participants with severe cardiovascular and cerebrovascular diseases or malignant tumors; (3) Participants with abnormal liver and renal function (creatinine =200µmol/L, alanine aminotransferase and aspartate aminotransferase levels elevated more than twice the upper limit of the normal range); (4) Participants with spinal cord injuries, cervical and lumbar spine diseases (nerve root compression, spinal canal stenosis, degenerative changes of the cervical and lumbar spine), or post-cerebrovascular accident sequelae, neuromuscular junction disorders, or muscle diseases; (5) Participants with severe arteriovenous vascular disease (such as venous thrombosis, lymphangitis, etc.); (6) Participants with epilepsy or psychiatric disorders, or a history of psychotropic drug abuse; (7) Participants allergic to any of the drugs in the TCM prescription used in this study; (8) Participants with obstructive arterial occlusion of the lower extremities, those who are planning pregnancy, pregnant, or lactating women; (9) Participants who have participated in other clinical trials within the past month. 2.Exclusion Criteria for DPN Participants in the Functional Magnetic Resonance Imaging (fMRI) Study Section: Based on the exclusion criteria for DPN participants in the clinical trial section, plus individuals with contraindications to magnetic resonance scanning, such as individuals with implanted metallic objects, pacemakers, metallic dentures (non-removable), or those with claustrophobia, or unable to undergo MRI due to other reasons. 3.Exclusion Criteria for Healthy Individuals in the fMRI Study Section: (1) Contraindications to MRI, such as having metal implants, cardiac pacemakers, non-removable metal dentures, claustrophobia, or other reasons preventing MRI scans; (2) Women who are planning pregnancy, pregnant, or breastfeeding; (3) Individuals with a history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toronto Scoring System (TCSS);Michigan diabetes Peripheral Neuropathy Score (MDNS);Traditional Chinese Medicine Syndrome Points;nerve conduction velocity;Brain functional magnetic resonance imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stanford Expectancy Treatment Scale;NEO Five-Factor Inventory;Demographic indicators (birth date, gender, age, height, weight, ethnicity, occupation, BMI or waist;Twelve lead conventional electrocardiogram;Glucose and Lipid Metabolism Indicators((fasting blood glucose, glycosylated hemoglobin (measured only at baseline), total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol));serum cytokines (serum superoxide dismutase (SOD), adiponectin (ADPN));blood routine examination;urine test;stool test;liver function;Renal function; | — |
Countries
China
Contacts
Public ContactSun Chunquan
Tsinghua University Yuquan Hospital
Outcome results
None listed