NCT03983200Unknown不适用
Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Majianhua0 个研究点目标入组 200 人开始时间: 2019年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Nerve conduction velocity examination
研究概览
简要总结
The aim of the study is to assess the effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate and sign informed consent prior to the study
- •Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy).
- •HbA1c<7.5%, the hypoglycemic regimen was stable for 3 months
- •No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
排除标准
- •Patients with foreign metal bodies or pacemakers
- •Patients with a history of surgery at magnetic therapy sites within one year
- •Patients with obvious discomfort to magnetic therapy
- •Patients with bleeding or bleeding tendency
- •Patients with acute complications such as diabetic ketoacidosis
- •Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal
- •History of drug abuse and alcohol dependence in the past 5 years
- •Systemic hormone therapy was used in the last three months
- •Patients with infection and stress within 4 weeks
- •Patients who are pregnant, breast-feeding, or intending to become pregnant.
- •Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases
研究组 & 干预措施
Control group
Sham Comparator
Mecobalamine 0.5mg, tid
干预措施: Mecobalamin (Drug)
Rotating Magnetic Therapy
Experimental
Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
干预措施: Rotating Magnetic Therapy (Device)
Rotating Magnetic Therapy
Experimental
Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
干预措施: Mecobalamin (Drug)
结局指标
主要结局
Nerve conduction velocity examination
时间窗: 1 month
the change of Nerve conduction velocity examination
次要结局
- Glycosylated serum albumin(1 month)
- MNSI(1 month)
研究者
Majianhua
Director, Head of Endocrinology department, Clinical Professor
Nanjing First Hospital, Nanjing Medical University
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