Painful Diabetic Peripheral Neuropathy
Conditions
Interventions
Experimental Group:Wenyang Sanhan Formula
Sponsors
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age: 20-80 years; 2) Meets diagnostic criteria for diabetes; 3) Meets diagnostic criteria for diabetic peripheral neuropathy; 4) Meets diagnostic criteria for PDPN; 5) Matches TCM syndrome differentiation of cold-dampness obstruction; 6) Pain score requirements: BPI-DPN pain score = 4 or VAS score = 4; 7) Voluntary participation with signed informed consent; 8) Permitted concomitant medications/treatments.
Exclusion criteria
Exclusion criteria: 1) Does not meet inclusion criteria; 2) Peripheral neuropathy caused by other factors (trauma, infection, etc.); 3) Surgery within 1 month prior to screening; 4) Recent infections or diabetic ketoacidosis; 5) Severe complications (foot infections, cardiovascular diseases, etc.); 6) Infectious diseases (syphilis, HIV, hepatitis B) or coagulation disorders; 7) Severe psychiatric conditions affecting pain assessment; 8) Pregnancy/lactation or unwillingness to use contraception; 9) Allergy to study medication components; 10) Substance abuse history; 11) Participation in other clinical trials; 12) Previous trial participation within 3 months; 13) Investigator-determined unsuitability; 14) Prohibited concomitant medications/treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetic Peripheral Neuropathy Pain Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale;Toronto Clinical Scoring System;Daily Sleep Interference Diary;Patient Global Impression of Change;Nerve Conduction Velocity Comparison;Traditional Chinese Medicine Syndrome Scale; | — |
Countries
China
Contacts
Public ContactChuangpeng Shen
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Outcome results
None listed