Observe the effectiveness and safety of Jinmaitong in the treatment of type 2 diabetic peripheral neuropathy
- Conditions
- Diabetic peripheral neuropathy
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients aged 20-75 years, regardless of gender;
2. The patients who met the diagnostic criteria for diabetes established by who in 1999 were classified as type 2;
3. Patients with diabetic or subsequent neuropathy;
Four Patients with at least 2 positive clinical symptoms (limb pain, numbness, tingling, soreness, weakness, etc.) and physical signs (ankle reflex, acupuncture pain, vibration, pressure and temperature) and consistent with the performance of DSPN; and there are neuroelectrophysiological abnormalities: nerve conduction velocity, amplitude, latency or F wave of at least two or more nerves (median nerve, common peroneal nerve, ulnar nerve) At least 1 exception.
5. Patients with kidney deficiency and blood stasis and cold coagulation meridians syndrome;
6. Patients who voluntarily participate and sign informed consent.
1. Patients with other systemic diseases that may cause peripheral neuropathy (including connective tissue disease, blood system disease, systemic amyloidosis, alcoholic peripheral neuropathy, etc.);
2. Patients with Guillain Barre syndrome, severe cervical and lumbar diseases, patients with chemotherapy due to malignant tumor, and patients with moderate stroke may cause similar symptoms of peripheral nervous system;
3. Patients with acute diabetic complications, including diabetic ketoacidosis, diabetic hyperosmolar coma, diabetic lactic acidosis, hypoglycemic coma, etc;
4. Patients with severe chronic diabetic complications (including diabetic retinopathy proliferative phase; diabetic nephropathy stage IV and above);
5. Patients with chronic gastrointestinal dysfunction with obvious digestive and absorption disorders, and other endocrine diseases such as hyperthyroidism, cortisol excess, acromegaly, etc;
6. Patients with severe heart disease, including acute myocardial infarction, unstable angina pectoris, and cardiac insufficiency (NYHA grade III and IV).
7. Patients with moderate or severe liver dysfunction, ALT or ast > 2 x ULN or TBIL > 2 x ULN (retest is allowed within one week), and patients with decompensated cirrhosis;
8. In patients with moderate to severe renal insufficiency, GFR < 30ml / min;
9. Patients with WBC < 4.0 x 10^9 / L or platelet count < 90 x 10^9 / L (retest is allowed within one week);
10. Patients who use drugs that affect glucose metabolism, such as glucocorticoids;
11. Patients who have serious diseases and are likely to die during the treatment and follow-up period;
12. Patients with serious mental and nervous system diseases and unable to express their wishes correctly have suicidal tendency in depression;
13. Women of childbearing age who are in pregnancy, lactation, pregnancy intention or pregnancy test (urine HCG or blood HCG) are positive, and can not take effective contraceptive measures (effective contraceptive measures include sterilization, intrauterine device, oral contraceptives);
14. Patients who have participated in clinical studies of other drugs in the past three months;
15. For patients with other diseases, the researchers believe that they will not be able to evaluate the curative effect or are unlikely to complete the expected course of treatment and follow-up;
16. Patients known to be allergic to the drugs used in this study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TCM symptom score;Quantitative sensory test;Electrochemical skin conductivity;Neurological score;
- Secondary Outcome Measures
Name Time Method HbA1c;fasting blood glucose (venous plasma, FBG);2 hours postprandial blood glucose (2h-PBG);1 hour postprandial blood glucose (1h-PBG);