Diabetes Peripheral Neuropathy
Conditions
Interventions
Kangfuxin liquid group:Kangfuxin liquid sterile solution
Placebo group:Sterilized water for injection
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? The age for signing the informed consent form during the screening period is between 18 and 70 years old (including 18 and 70 years old), regardless of gender; ? Subjects who were diagnosed as type 1 or type 2 diabetes according to the World Health Organization (WHO) diabetes diagnostic criteria in 1999, and who were clinically diagnosed as diabetes peripheral neuropathy according to clinical symptoms, signs and/or electrophysiological evidence, and who were treated with hypoglycemic therapy for 3 months or more; ? According to the researcher's judgment, individuals with stable blood glucose control within the first three months of screening, and glycated hemoglobin A1c Protein (HbA1c)>6.5% and6 points; ? Be able to fully understand the purpose and requirements of this trial, be willing to strictly follow the clinical research protocol to complete this study, voluntarily participate in the clinical trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: ? Patients with peripheral neuropathy caused by other diseases, such as cervical and lumbar spine diseases, cerebrovascular diseases, toxic peripheral neuropathy, Guillain Barre syndrome, bone or tendon lesions, severe arteriovenous disease, uremia, and chronic kidney disease with stage III or above staging, hyperthyroidism or hypothyroidism, subclinical thyroid dysfunction, intracranial tumors, trauma, etc; Combined with severe autonomic neuropathy; ? There is a history of acute complications of diabetes in the recent 6 months, such as diabetes ketoacidosis, diabetes hyperosmolar hyperglycemia syndrome or lactic acidosis; ? Patients with peripheral arterial diseases, those with significant intermittent claudication symptoms during screening, or those who have previously undergone lower limb vascular bypass surgery or angioplasty; Suffering from significant cardiovascular and pulmonary diseases: unstable angina, severe arrhythmia; Or have a history of myocardial infarction, cerebrovascular accidents (such as acute cerebral hemorrhage, acute cerebral infarction), or transient ischemic attacks within 6 months prior to enrollment; Or uncontrollable asthma or shortness of breath in the two months prior to enrollment; During the screening visit, the researchers determined participants in the WHO Heart Function Classification III-IV; When screening, systolic blood pressure>160mmHg or diastolic blood pressure>90mmHg; ? During the screening visit, any researcher considered that various infections were not suitable for participating in the study, including but not limited to those complicated with various infections requiring further treatment, such as urinary tract infection, respiratory tract infection, and diabetes foot infection; ? Abnormal liver and kidney function during screening has clinical significance: aspartate transaminase (AST) or alanine transaminase (ALT), or total bilirubin or creatinine>2 times the upper limit of normal (ULN); ? Subjects who are known to be allergic to the components of the rehabilitation solution; ? When screening, there is a history of severe systemic or mental illness, epilepsy; ? Subjects with a history of malignant tumors (excluding cured basal cell carcinoma, in situ carcinoma, and papillary thyroid carcinoma) or anti-tumor therapy within the 5 years prior to the screening visit; ? Subjects with severe hemorrhagic diseases; ? Abnormal thyroid function during screening (clinically significant abnormalities detected in free triiodothyronine (FT3), free thyroxine (FT4), and thyroid stimulating hormone (TSH) tests), including those in subjects undergoing treatment; ? Known human immunodeficiency virus (HIV) infected individuals or individuals with positive serum Treponema pallidum antibodies during creening; ? Screening and baseline Toronto Clinical Neurological Scale (TCSS) with a change of 2 points or more in the same item; ? Any situation found during the screening visit where the researcher believes that the study medication does not meet the safety administration standards, cannot comply with the study visit schedule, is unable to safely participate in the study, or affects the study results; ? According to the judgment of the researchers, the subjects have any other medical history or significant clinically significant changes that may confuse the research results or damage various systems (mainly including but not limited to hematology, kidney, liver, endocrine, lung, digestion, cardiovasc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nerve Conduction Velocity; | — |
Secondary
| Measure | Time frame |
|---|---|
| TSCC;Biochemical indicators: blood glucose, glycated hemoglobin, CRP, tumor necrosis factor, interleukin-6; | — |
Countries
China
Contacts
Public ContactQi Pan
Beijing Hospital
Outcome results
None listed