A clinical evaluation of Guda Shunthi Avapeeda Nasya and Pathyadi Kwatha in the management of Ardhavbhedaka wsr to migraine an open label single arm study
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
- relief in headache in terms of frequency, duration and severity
研究概览
简要总结
The disease Ardhavbhedaka is included in Shiroroga in Ayurvedic classics having hemicrainal pain as its cardinal feature. The pain involves Pradhan Marma- Shira hence very troublesome for the patient.The symptoms of Ardhavbhedaka are similar to those of Migraine.In the Global Burden of Disease Study2010 (GBD2010), it was ranked as the third most prevalent disorder in the world. In GBD2015, it was ranked third–highest cause of disability worldwide in both males and females under the age of 50 years.[i] Almost 1.04 billion individuals were estimated to have migraine. It caused 45.1 million YLDs(years of life lived with disability) globally in 2016. It is most burdensome in women between ages 15 and 49 years, causing 20.3 million YLDs in 2016, which was 11.2% of all YLDs in this age group and sex. To get rid of the pain the patient has to take some medication which may show some side effects or durg dependancy or withdrawl symptoms. Ayurvedic manegement of migraine includes instillation of drug through nasal route (Nasya)along with oral medicines. This helps in reliving symptoms faster. Role of Nasya in Ardhavbhedaka is established but the specific combination of Guda(Jeggary) and Shunthi (powder of Gingibar officinale) Avapeeda Nasya has not been tried yet .In this study the relief in symptoms will be observed and difference in MIDAS score will be observed.
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
- •Pain in neck eyebrows temples ear eyes and frontal area Pain on every 10 15 30 days interval or sudden onset Nausea Vomiting vertigo Aura GI tract symptoms Associated with sensitivity to light sound and movement Chronicity of the disease up to 10 years Nasya Yogya.
排除标准
- •Age less than 18 years and above 60 years Chronicity of the disease more than 10 years will be excluded Patients suffering from any chronic debilitating disease with other neurological pathology ENT pathology and cases which require surgical intervention will be excluded from study Patients suffering from sinusitis, hypertension secondary headache caused by meningitis tumour encephalitis cervical spondylitis and refractive errors will be excluded from study Patients using any other systemic drugs which may alter the results of study Pregnant lady and lactating mother Nasya Ayogya.
结局指标
主要结局
relief in headache in terms of frequency, duration and severity
时间窗: 0 week, 6 weeks
次要结局
- Changes in MIDAS score(0 week, 6 weeks)
研究者
Dr Kunjal Bhatt
J S ayurveda mhavidyalaya