liuweiluobi granule for the treatment of diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy; Chinese Medicine; Nerve Conduction

Summary: based on network pharmacology, liuweiluobi granule was screened to treat diabetes peripheral neuropathy with deficiency of the spleen and kidney and stasis-heat syndrome.in the preliminary animal experiment, it suggested that this granule had a significant protective effect on the peripheral motor nerves of diabetic peripheral neuropathy and the effect of anti-inflammation, and the prescription did not induce the death of zebrafish at a concentration of 1000 ug/ml, without any obvious toxicity. this study aims to evaluate the efficacy of liuweiluobi granule in improving neurotransmission function in patients with diabetic peripheral neuropathy through a pilot, randomized controlled study.


Eligibility criteria:
inclusion criteria 1. meet the clinical confirmed diagnostic criteria of "diabetic peripheral neuropathy"; 2. toronto score ≥ 6 points; 3. meet the chinese medicine diagnostic criteria of pi-shen-liang-xu (deficiency of pi and shen) and yu-re-ru-luo (collaterals with stasis and heat） zheng (syndrome) in diabetic peripheral neuropathy; 4. over 18 years old and under 75 years old, regardless of gender and ethnicity; 5. have received basic treatment for diabetes controled with stable blood glucose level (fasting blood glucose: \<7mmol / l; 2h postprandial blood glucose: \<11.1mmol / l; glycated hemoglobin: \<8%); 6. have not taken or stopped taking dpn-related drugs (mutan granules, qidan tongluo granules, pregabalin, duloxetine, etc.) for more than one week; 7. sign the informed consent form with valid telephone contact information. exclusion criteria 1. patients with diabetic ketosis, ketoacidosis or co-infection; 2. patients with known malignant tumors; 3. patients with known severe brain diseases, as cerebral infactions with limited activity； 4. patients with known severe arrhythmias or heart failure over grade 2 (new york heart association), or other known severe heart diseases; 5. patients with known severe kidney impairment (creatinine ≥200ummol/l); 6. during the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-alt and/or ast level\> 2 times the upper limit of normal range (uln); 7. patients with spinal cord injury, cervical and lumbar spine lesions (nervous root compression, spinal stenosis, cervical and lumbar degenerative lesions) or sequelae of cerebrovascular disease, neuromuscular junction or muscle disease; 8. patients with other neuropathy diseases caused by, such as: cerebral infarction, guillain-barre syndrome, severe arteriovenous vascular disease (venous embolism, lymphangitis), chronic inflammatory demyelinating polyneuropathy, vitb deficiency, hypothyroidism, alcoholism, neurotoxicity indused by chemotherapeutic drugs, or metabolic nerve damage caused by renal insufficiency; 9. patients with severe arteriovenous vascular disease (venous embolism, lymphangitis, etc.); 10. patients with epilepsy or mental illness; 11. alcoholics; 12. patients with a history of psychotropic substance abuse; 13. patients with allergies or allergies to any drugs in the trial; 14. pregnant women or patients with intention to become pregnant; 15. participated in other clinical trials in the past 1 month; 16. patients would not take drug continuously which could affect the evaluation of efficacy; 17. investigator evaluates as unsuitable to participate in this clinical trial.