Efficacy of Nasal spray made of selected drugs of Aṇutaila against Nasya of Aṇutaila in Chronic sinusitis – A Randomised Controlled Noninferiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 1 Scale for scoring symptoms of Chronic sinusitis
研究概览
简要总结
A randomised controlled non inferiority trial is planned in chronic sinusitis to compare anuthaila nasya and nasal spray made of selected drugs of anuthaila. Chronic sinusitis is a kapha pradhana vyadhi that shows seasonal flare ups and requires frequent sodhana. Nasya with anuthaila is having notewothy excretory action but patient complaince is low. Nasal spray is prepared as a combination of distillate and kasaya of selected drugs of anuthaila. The safety is assesed by event evaluation scale and anterior rhinoscopy. An assessment of efficacy will be done using the Scale for scoring of symptoms of Chronic sinusitis, Rhinosinusitis Disability Index (RDI) and Visual Analogue scale (VAS) for pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Participants fulfilling diagnostic criteria 2 Participants indicated for nasya 3 Participants of all gender in between age 18 and 60 years 4 Those who have willingness to participate in the study.
排除标准
- •1 Blood-stained nasal discharge 2 Nasal polyp 3 H/o polypectomy and sinus surgery within 3 months 4 Uncontrolled Diabetes Mellitus and Hypertension 5 Pregnant/ lactating women 6 History of hypersensitivity to the trial drug 7 Any other condition that may jeopardize the study.
结局指标
主要结局
1 Scale for scoring symptoms of Chronic sinusitis
时间窗: 0,7,14 and 30th day
2 Rhinosinusitis Disability Index15
时间窗: 0,7,14 and 30th day
3 Visual Analogue Scale for pain
时间窗: 0,7,14 and 30th day
4 Samyak nasya lakshana assessment proforma
时间窗: 0,7,14 and 30th day
5 Event Evaluation Scale
时间窗: 0,7,14 and 30th day
次要结局
- HPTLC GC Of nasal spray of selected drugs of anuthaila(6 months)