Comparative clinical trial to evaluate the effect of Pippalyasava and nimbasava nasya in chronic rhinosinusitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Nasal Signs and Symptoms Score
研究概览
简要总结
Chronic rhinosinusitis is an inflammatory condition affecting the paranasal sinuses that lasts
for more than 12 weeks. The clinical features include nasal discharge, nasal obstruction,
disturbance of smell and headache.
In Ayurveda, this condition can be correlated with Dushtapratishyaya based on its
symptoms. As Dushtapratishyaya is an Urdhva jatrugata vyadhi, nasya is considered as the
best treatment option. Asava is indicated for shodhana nasya in Ayurvedic classics. The effect
of Nimbasava and Shirovirechana gana dravya siddha asava nasya in this conditions has been
proven in previous studies. So, this study is planned to compare the effect of Pippalyasava and
Nimbasava nasya in chronic rhinosinusitis.
A comparative clinical trial with 38 participants satisfying the inclusion criteria will be selected
from the outpatient department of Shalakyatantra, Government Ayurveda College Hospital,
Kannur. Group A and Group B will be administered Pippalyasava and Nimbasava nasya
respectively. The effect of both the interventions will be assessed by the improvement in Nasal
Signs and Symptoms Score and Visual Analogue Scale (VAS Scale) evaluated from the
baseline, on the 6th day and follow-up on 15th day. Result will be statistically analysed
after the study.
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
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with chronic rhinosinusitis within 1 month by X-rays
- •Chronicity greater than 12 weeks
- •Participants with 2 or more signs and symptoms such as nasal obstruction, mucopurulent discharge, facial pain, decreased sense of smell
- •Subjects who are willing to give written informed consent.
排除标准
- •Subjects with clinical features of any complication of Chronic rhinosinusitis.
- •Subjects who are advised for surgical procedure.
- •Subjects with any chronic debilitating infectious diseases.
- •Subjects with nasal polyp.
- •Subjects with any evidence of nasal tumors.
- •Subjects with a history of nasal bleeding.
结局指标
主要结局
Nasal Signs and Symptoms Score
时间窗: 0th, 6th and 15th
VAS Scale
时间窗: 0th, 6th and 15th
次要结局
未报告次要终点
研究者
Dr Aswathi I
Government Ayurveda College Pariyaram Kannur