A Clinical Study To Evaluate the Effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals
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
- 1.Urah Laghavam (Lightness in chest region)
研究概览
简要总结
This study is an open label, single arm, prospective, clinical study to evaluate the effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals that will be conducted in India. The primary outcome measures will be samyaka lakshanas of Nasya that will be assessed before treatment and everyday of Nasya for 7 days and after Nasya on 8th day. Respiratory health of subjects will be analyzed using MRC Breathlessness Scale. The secondary outcome measures will be the collected swab samples to analyze number and variety of microorganisms present in the nasal flora and this will be assessed before and after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aging between 18 to 50 years
- •Subjects of all gender
- •Subjects without any history of acute or chronic respiratory diseases
- •Subjects who are fit for Pratimarsha Nasya
- •Subjects willing to sign informed consent form.
排除标准
- •Subjects with history of nasal polyp, Deviated nasal septum, any acute or chronic respiratory illness
- •Subjects with chronic systematic diseases like HIV, HBsAg etc
- •Subjects vaccinated with Covid Vaccine in last three months
- •Subject having history of antibiotics intake in last three months.
结局指标
主要结局
1.Urah Laghavam (Lightness in chest region)
时间窗: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
2.Shiro Laghavam (lightness in head region)
时间窗: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
4.Sroto Vishudhi (clearance of bodily channels)
时间窗: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
Time taken to achieve Samyaka Lakshanas of Nasya will be observed:
时间窗: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
3.Indriyaatacchyam (clearity of sesnse organs)
时间窗: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
次要结局
- Respiratory health of subjects will be analyzed using MRC Breathlessnes Scale(The collected swab samples will be analyzed for the number and variety of microorganisms present in the nasal flora)