CTRI/2023/05/052590尚未招募Unknown
A prospective randomised double arm parallel Clinical study To compare the effectiveness of constitutional versus therapeutic remedies in the management of migraine.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2006) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
- •Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
- •Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
- •Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed.
排除标准
- •Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
- •History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
- •Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
- •Women who are pregnant or nursing
- •Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
- •Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
- •Unwilling to take part and not giving consent to join the study or unable to read patient information sheet.
研究者
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