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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
LiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc.
Standard medical therapy is adhered to the guidline issued by American Diabetes Association and Chinese Diabetes Society at 2017, including keeping an appropriate diet, doing some exercises, the pharmacological therapy to control the blood glucose, blood pressure and blood lipids.
Yuquan Hospital of Tsinghua University
Beijing, Beijing Municipality, China
RECRUITINGMean maximal nerve conduction velocity
Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)
Time frame: 12 weeks
Michigan Diabetic Peripheral Neuropathy Score (MDNS)
Michigan Diabetic Peripheral Neuropathy Score (MDNS) is a 46 point clinical score, with score ranging from 0 to 3 (score of 0, normal; 1, mild to moderate; 2, severe and score of 3, absent). The score is more high means a worse outcome.In MDNS vibration, pain, and light touch are assessed with a 128 Hz tuning fork, a pin, and a 10g filament, respectively. The outcome measures were performed by the investigator at baseline and at the eighth week.
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Toronto clinical scoring system (TCSS)
Toronto clinical scoring system (TCSS) includes three parts: the symptom score of the symptom, the reflection score of the nerve and the evaluation score of the sensory function test. Symptoms include numbness, pain, and needle-like sensation in the lower extremities Feelings of weakness, weakness, instability in walking, and similar symptoms of the upper limbs, such as normal score of 0, 1 point for the presence of corresponding symptoms, a total of 6 points; nerve reflex including ankle reflex and knee reflex, bilateral score, normal score of 0, weakened 1 point, 2 points for disappearance, 8 points in total; sensory function test includes 5 items of pain, temperature, pressure, vibration, and position on the right big toe, 0 points for normal, 1 point for abnormality, 5 points in total With a total score of 19 points. With a score of 0 to 5 do not exist in the DPN, 6 to 8 are mild DPN, 9 to 11 are moderate DPN, 12 to 19 are severe DPN.
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Quantitative symptoms scales of DPN in Traditional Chinese medicine
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
HbA1c
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Changes in the level of aldose reductase
Time frame: to 12 weeks
Fasting blood glucose
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
2 hrs postprandial blood glucose
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Total lipids (TC)
Lipid level
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
triglycerides (TG)
Lipid level
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
high density lipoprotein cholesterol (HDL-C)
Lipid level
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
low density lipid Protein cholesterol (LDL-C).
Lipid level
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
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