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临床试验/NCT04509141
NCT04509141已完成不适用

Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline

Indonesia University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
duration

研究概览

简要总结

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.

详细描述

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families. With the high prevalence and disability rates for migraine sufferers, on the other hand, the right treatment for migraine has not yet been obtained to the maximum, it is necessary to deepen the treatment and prevention of migraine is needed, and until now there has been no definitive cure, both for prevention and treatment, so it is necessary to develop therapies that can provide more accurate relief for migraine sufferers. The purpose of this study is to assess the success in managing migraine in reducing the frequency of attacks, reducing the intensity of attacks and reducing the duration of attacks from weeks 0, 4 to 8

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

the patient did not know that there were two groups divided in each participants, and the doctor who measures the outcome also did not know which person belongs to which group

入排标准

年龄范围
19 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • subjects aged 19-50 years
  • subjects with history of clinical diagnosis of migraine (interictal period)
  • signed research approval forms, and were willing to take the study to completion.

排除标准

  • subjects with pregnancy,
  • lesions, wounds, infections and suffering from malignant diseases or tumor and thrombophlebitis in the area at the selected acupuncture point
  • increasing liver function three times above normal values.

结局指标

主要结局

duration

时间窗: at week 8

Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid

intensity

时间窗: at week 8

Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid

frequency

时间窗: at week 8

Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Newanda Johni Muchtar, Sp. Ak

Principal Investigator

Indonesia University

研究点 (2)

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