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临床试验/NCT03805035
NCT03805035已完成不适用

Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月24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
状态
已完成
入组人数
40
试验地点
1
主要终点
pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)

研究概览

简要总结

Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is increasingly practiced worldwide. The effects of acupuncture in chronic pain have been investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, investigators found that histamine H1 receptor antagonists at relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing test. Investigators aim to further explore whether histamine H1 receptor antagonists also facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36 and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain threshold. It is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • . Age: 20 to 30 years of age.
  • . Agrees to undergo a comprehensive medical history and physical examination.
  • . No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.

排除标准

  • . An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).
  • . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
  • . An implant such as a pacemaker, defibrillator, or electronic medical equipment.
  • . Pregnancy, or planning for pregnancy.

研究组 & 干预措施

sham EA group

Sham Comparator

Minimal needling at ST36 and GB34 (n=10)

干预措施: acupuncture (Device)

true EA group

Experimental

EA at ST36 and GB34 (n=10)

干预措施: electroacupuncture (Device)

EA+antihistamine(low dose) group

Active Comparator

EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)

干预措施: electroacupuncture (Device)

EA+antihistamine(low dose) group

Active Comparator

EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)

干预措施: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate) (Drug)

EA+antihistamine(high dose) group

Active Comparator

EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)

干预措施: electroacupuncture (Device)

EA+antihistamine(high dose) group

Active Comparator

EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)

干预措施: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate) (Drug)

结局指标

主要结局

pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)

时间窗: baseline and 10min after treatment

Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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