Diabetic Peripheral Neuropathy
Conditions
Interventions
Standard western medicine treatment group:Oral intake
Chinese medicine treatment group:Oral intake
Sponsors
Renji Hospitao Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Between 18-80 years old; 2. Conforms to the American Diabetes Association (ADA) 2016 diagnostic criteria for type 2 diabetes; 3. In line with the "Diabetic Peripheral Neuropathy Clinical Diagnosis and Treatment Guidelines (2016 Edition)" Qi deficiency and blood stasis syndrome type: limb weakness numbness, such as ants, end pain, mostly tingling, mainly lower limbs, pain at night Tiredness, shortness of breath, lazy talk, sweating when moving, diarrhea or constipation, dark tongue, or petechiae, thin white fur, fine pulse; 4. Any limb has pain or burning or numbness or loss of feeling or weakness, and the Modified Toronto Clinical Neuropathy Score (mTCNS) =1; or previous NCV abnormalities, clinical considerations related to DPN; 5. Have a stable blood glucose treatment plan, glycated hemoglobin (HbA1c) <8%; 6. Voluntary participation in clinical research and willing to cooperate with the completion of the trial.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, preparing for pregnancy or breastfeeding; 2. A history of diabetic ketoacidosis or nonketotic hyperosmolar coma in the past month; 3. Severe cardiopulmonary diseases, including uncontrolled angina, cardiac insufficiency, acute COPD attack, pacemaker implantation history, etc .; 4. Suffering from tumor, autoimmune disease, or diagnosed with immune, toxic, hereditary and other metabolic peripheral neuropathy; 5. Abnormal renal function: Cr rises more than twice the normal value, or has a history of hematuria and renal insufficiency; 6. Abnormal liver function: ALT and AST increase more than 3 times normal; 7. Allergic constitution; 8. Prolonged alcoholism; 9. Those who are participating in other clinical trials or those who have participated in similar clinical drug trials within 1 year; 10. Those who do not cooperate or are unable to cooperate and cannot follow the treatment plan; 11. The investigator believes that the patient is not suitable for other conditions in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified neurological disability score;Michigan Neuropathy Screening Instrument;Michigan DiabeticNeuropathy Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale/Score;Nerve Conduction Velocity;Intraepidermal nerve fiber density; | — |
Countries
China
Contacts
Public ContactYangtai Guan
Outcome results
None listed