A comparative experimental study to assess the efficacy of administration of individualised homoeopathic medicine in solid globule form and liquid dilution form in treatment of migraine.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in migraine-related disability or pain measured by MIDAS score.
研究概览
简要总结
Migraine is a common and disabling neurological disorder, often managed with Homoeopathy. Traditionally, medicines are given in solid globule form, but liquid dilution form is also widely used. This study aims to compare the effectiveness of individualized Homoeopathic medicines administered in solid globule versus liquid dilution forms in patients with migraine.
A total of 50 patients (25 in each group) will be enrolled and randomized. Diagnosis will be based on ICHD-3 criteria. The primary outcome will be reduction in disability as measured by the Migraine Disability Assessment (MIDAS) score. Secondary outcomes will include frequency and intensity of attacks, patient compliance, satisfaction, and recurrence rates. The study duration is 12 months, with follow-ups every 15 days.
The trial is expected to provide clinical evidence on whether the dosage form (globules or liquid dilution) influences therapeutic outcomes in migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Diagnosed cases of migraine based on International Classification of Headache Disorders (ICHD-3).
- •Willing to give written informed consent.
- •Able to comply with research and follow ups.
排除标准
- •Patients with other types of headache (tension-type, cluster, etc.).
- •Any Known psychiatric disorders Pregnant or lactating women.
- •Participation in other study within the last 3 months.
结局指标
主要结局
Reduction in migraine-related disability or pain measured by MIDAS score.
时间窗: Baseline(Day 0) | Follow up every 15 days up to 12 months
次要结局
- Change in frequency and intensity of migraine attacks during the study period.(Patient compliance with prescribed mode of medicine administration (globule vs. liquid).)
研究者
Santoki Bhavik Lavjibhai
Rajkot Homoeopathic Medical College
