A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean maximal nerve conduction velocity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LiuWeiLuoBi Group
Patients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment.
干预措施: LiuWeiLuoBi Granule (Drug)
LiuWeiLuoBi Group
Patients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment.
干预措施: Standard medical treatment (Other)
Control Group
Patients will receive the standard medical treatment for 12 weeks.
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Mean maximal nerve conduction velocity
时间窗: 12 weeks
Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)
次要结局
- HbA1c(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Changes in the level of aldose reductase(to 12 weeks)
- Total lipids (TC)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- triglycerides (TG)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- high density lipoprotein cholesterol (HDL-C)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- low density lipid Protein cholesterol (LDL-C).(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Michigan Diabetic Peripheral Neuropathy Score (MDNS)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Toronto clinical scoring system (TCSS)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Quantitative symptoms scales of DPN in Traditional Chinese medicine(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Fasting blood glucose(Baseline, 4 weeks, 8 weeks and 12 weeks)
- 2 hrs postprandial blood glucose(Baseline, 4 weeks, 8 weeks and 12 weeks)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences