LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences

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.