Construction of Key Technology and Study of the Effect Mechanism of Moxibustion in the Treatment of Diabetic Peripheral Neuropathy Based on Optimal Selection of Acupoints and Moxibustion Volume
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Total clinical effectiveness
研究概览
简要总结
This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of diabetes mellitus;
- •Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score >5;
- •18 years ≤ age ≤ 80 years;
- •Gender is not limited;
- •Those who have the ability of independent daily life and can cooperate to complete all the examinations;
- •Those who are conscious without serious mental diseases and cognitive disorders, and those who do not have serious cardiac, cerebral, hepatic, renal and other internal diseases;
- •Voluntary participation and signing of informed consent.
排除标准
- •Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
- •Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
- •Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
- •Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
- •Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
- •Those who are participating in other acupuncture or drug clinical trials.
结局指标
主要结局
Total clinical effectiveness
时间窗: After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)
Overall clinical effectiveness was assessed at 2 time points: after 4 weeks of treatment and during the follow-up period (the 6th week). It was classified into the following 3 grades according to the Guidelines for Clinical Study of New Chinese Medicines: 1. Cure: clinical symptoms such as limb numbness, coldness and chilling pain, sensory abnormalities, muscle weakness and muscle atrophy disappear, tendon reflexes return to normal, and the total score of TCSS is ≤ 5 points; 2. Effective: numbness of the limbs, cold and chilling pain, sensory abnormalities, muscle weakness myasthenia and other clinical symptoms significantly improved, tendon reflexes returned to normal, TCSS score level 2 or 1 level lower; 3. Ineffective: clinical symptoms did not improve or worsen, tendon reflexes were not elicited, and TCSS score grade did not decrease or increase. Total effective rate = \[(number of cured cases + number of effective cases)/total number of cases\] × 100%.
次要结局
- Visual Analogue Scale(The week 0, the 4th week and the 5th-8th week)
- infrared thermography testing(The week 0 and the 4th week)
- Electrophysiological examination of the peroneal nerve of the lower limb(The week 0 and the 4th week)
- Traditional Chinese Medicine Syndrome Score Scale(The week 0, the 4th week and the 5th-8th week)
- Toronto Clinical Scoring System(The week 0, the 4th week and the 5th-8th week)
- Electrophysiological examination of the tibial nerve of the lower limb(Baseline (week 0) and the 4th week)
研究者
Yongliang Jiang
Professor
Zhejiang Chinese Medical University