LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Early Phase 1

Conditions: Nerve Conduction; Chinese Medicine; Diabetic Peripheral Neuropathy

Treatments: Other: Standard medical treatment; Drug: LiuWeiLuoBi Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT04457531

LIUWEI-V1.1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

LiuWeiLuoBi Group

Experimental group

Description:

Patients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment.

Treatment:

Drug: LiuWeiLuoBi Granule

Other: Standard medical treatment

Control Group

Other group

Description:

Patients will receive the standard medical treatment for 12 weeks.

Treatment:

Other: Standard medical treatment