An open labeled single arm clinical trial on the Efficacy of Pankajakasthuri Migraine Oil in migraine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the severity and frequency of migraine headaches
研究概览
简要总结
Migraine is a prevalent and debilitating neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by nausea, vomiting, and sensitivity to light and sound. This condition not only impairs individual quality of life but also contributes to significant healthcare burdens globally. Current treatments, primarily analgesics and triptans, can result in adverse effects and are not universally effective. This study aims to evaluate the efficacy of Pankajakasthuri Migraine Oil, an Ayurvedic formulation, in managing migraine without aura. A total of 40 subjects diagnosed with migraine without aura will be recruited from the outpatient department (OPD) of Pankajakasthuri Ayurveda Medical College and Hospital in Kattakada, Thiruvananthapuram. Participants will receive Pankajakasthuri Migraine Oil for six months, with assessments based on the severity, duration, and frequency of migraine attacks, as well as accompanying symptoms such as nausea, photophobia, and phonophobia. Quality of life will also be evaluated using established metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-60 years
- •Diagnosis of migraine
- •Both fresh and previously treated cases will be considered
- •Subjects of any sex
- •Migraine attacks occurring 1-6 times per month
- •History of migraine attacks for over one year.
排除标准
- •Subjects diagnosed with other primary headache disorders
- •Referred pain due to eye, ear, nose, throat, or dental disorders
- •Systemic disorders that could interfere with treatment outcomes.
结局指标
主要结局
Change in the severity and frequency of migraine headaches
时间窗: The severity of migraines will be assessed using a validated scale, such as the Visual Analog Scale (VAS) or the Migraine Disability |  Baseline: Prior to treatment initiation (Day 0). |  30 Days: Post-treatment, patients will report the severity and frequency of migraines. |  90 Days: Follow-up assessment to determine sustained changes. |  180 Days: Long-term assessment of treatment effectiveness.
次要结局
- • Changes in nausea, photophobia, phonophobia, and quality of life assessed at baseline and after six months of treatment.(• Adverse effects will be monitored throughout the study period, and any reports will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation