A randomized open label double arm controlled clinical study to evaluate the efficacy of Viddhakarma and Pathyadi Kashaya tablets in the management of Ardhavabhedhaka (migraine)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study is a randomized open label double arm controlled clinical trial to evaluate the efficacy of Viddhakarma and Pathyadi Kashaya tablets in the management of Ardhavabhedaka Migraine. Forty participants aged 20 to 45 years will be randomly assigned into two groups. Group A will receive Viddhakarma with Pathyadi Kashaya decoction and Group B will receive Viddhakarma with Pathyadi Kashaya tablets. The treatment duration is 30 days with assessments at baseline, day 1, day 15 and day 30. Primary outcomes include duration severity and frequency of pain along with associated symptoms such as nausea vomiting and tenderness. Secondary outcomes include photophobia phonophobia and HIT 6 scores. The study aims to establish whether Pathyadi Kashaya tablets provide effective safe and convenient management of migraine compared to the traditional decoction form.
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
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects between 20-45 years of age irrespective of sex and willing to participate and provide consent will be included.
- •Subjects having minimum of one episode of headache in 7 days
- •Subjects with clinical features of Ardhavabhedaka (migraine)
- •Subjects attending OPD during Vegavastha of Ardhavabhedaka (Pain Phase of Migraine)
- •Subjects indicated for Rakthamokshana as per classics.
排除标准
- •Subjects with other primary headache like tension, cluster headache
- •Subjects associated with secondary headache due to Glaucoma, Frontal sinusitis.
- •Subjects with systemic disorders that interfere the course of treatment (Diabetes Mellitus, Hypertension)
- •Pregnant and lactating women.
研究者
Dr Pooja Soni V
SDMIAH, Bangalore