A Single Arm Open Label Clinical Study to Evaluate the Efficacy of Laghu Sutshekhar Ras and Anu Taila Nasya along with Pathyadi Kwath in the Management of Ardhavbhedaka (Migraine)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant improvement in signs and symptoms of Ardhavbhedaka (Migraine).
研究概览
简要总结
The present study entitled *A Single Arm Open Label Clinical Study to Evaluate the Efficacy of Laghu Sutshekhara Ras and Anu Taila Nasya along with Pathyadi Kwath in the Management of Ardhavbhedaka (Migraine)*will be conducted to assess the effectiveness of Ayurvedic formulations in relieving migraine symptoms.
Ardhavbhedaka, described in Ayurvedic texts, closely resembles migraine, which is characterized by recurrent unilateral headaches often accompanied by nausea, vomiting, and photophobia.
In this study, patients diagnosed with Ardhavbhedaka will be treated with Laghu Sutshekhara Ras orally, Anu Taila Nasya as nasal therapy, and Pathyadi Kwath as an adjuvant for a specific duration. The study will be conducted on 30 patients from opd/ipd of Institute for Ayurved Studies and Research Hospital, Kurukshetra Haryana.
The study follow a single-arm, open label design, allowing direct observation of therapeutic outcomes. Assessment will be done before and after treatment based on the frequency, duration, and intensity of headache attacks, as well as associated symptoms.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with sign and symptoms of Ardhavabhedaka (Migraine with or without aura) will be selected irrespective of Sex, Religion and Profession.
- •Patients those are fit for Nasya Karma according to Ayurveda text.
- •Patients who have given written consent to participate in the study.
排除标准
- •Age group less than 18 years and more than 50 years. The patient having any systemic illness, like.
- •Diabetes mellitus, Hypertension, Tuberculosis, Hypotension & fever etc. Patients suffering from head injury, and other type of headaches except migraine. Patients Contraindicated for Nasya Karma. Patients unwilling to provide written consent for participation are excluded. Pregnant and lactating mothers. Secondary headache caused by sinusitis, meningitis, brain tumour, encephalitis, cervical spondylitis etc. Patients with any inflammatory disease. Patients requiring surgical treatment (eg- for nasal polyp). Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
结局指标
主要结局
Significant improvement in signs and symptoms of Ardhavbhedaka (Migraine).
时间窗: Follow up of patient will be done on 15th, 35th day of the treatment.
次要结局
- Improvement in mental & physical well being of patient.(Follow up on 15th , 30th day after treatment .)
研究者
Dr Vandana Saini
Institute for Ayurved Studies and Research Kurukshetra Haryana