CTRI/2023/05/052590尚未招募不适用
"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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment will be done using MIDAS SCALE
研究概览
简要总结
This study is " A prospective randomised double arm parallel Clinical study" To compare the effectiveness of constitutional versus therapeutic homeopathic remedies in the management of migraine.
Research question is - is there any significant difference between the two comparable groups ie. constitutional remedies and therapeutic remedies in the management of migraine.
Objectives are to assess the treatment outcome by using MIDAS scale.
Study duration is one year, 60 patients are included in the study, patients are followed every month upto 1 year. Outcome will be measured one at baseline and other at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 17.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Assessment will be done using MIDAS SCALE
时间窗: One at the baseline and other at the end of the study
次要结局
- Depending upon the severity of the symptoms and as per the need and necessity of the case(Every 2 weeks)
研究者
研究点 (1)
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