Clinical trial NCT04457531: LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
Official title: A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetic Peripheral Neuropathy
Chinese Medicine
Nerve Conduction
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Mean maximal nerve conduction velocity
timeFrame: 12 weeks
Secondary outcomes:
measure: Michigan Diabetic Peripheral Neuropathy Score (MDNS)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Toronto clinical scoring system (TCSS)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Quantitative symptoms scales of DPN in Traditional Chinese medicine
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: HbA1c
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Changes in the level of aldose reductase
timeFrame: to 12 weeks
measure: Fasting blood glucose
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: 2 hrs postprandial blood glucose
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Total lipids (TC)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: triglycerides (TG)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: high density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: low density lipid Protein cholesterol (LDL-C).
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
Other outcomes:
measure: Amino acids, lipid metabolites, vitamins, neurotransmitters and other metabolites
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
Locations:
city: Beijing
country: China
facility: Yuquan Hospital of Tsinghua University
state: Beijing
Study officials:
affiliation: China Academy of Chinese Science
name: Zhong Wang, Ph.D
role: STUDY_CHAIR
References: