LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

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.

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.