A RANDOMIZED CONTROLLED CLINICAL STUDY OF KATPHALA SIDDHA TAILA PRATIMARSHA NASYAIN RHINITIS.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- VAS value to decrease in pain by 2-3, number of sneezing to decrease by 2-3 times/days, difficulty in breathing and inflammation of nasal mucosa to decrease from severe to moderate or moderate to mild will be considered as positive effect.
研究概览
简要总结
A randomized controlled clinical study of katphala siddha taila pratimarsha nasya will be done on 62 patients presenting with complaints of Rhinitis and they will be divided into 2 groups (A & B). Group A will be provided with the trial drug, katphala siddha taila and will be advised to instill 2 drops in each nostril in the morning and evening for 7 days. Group B will be provided with the control drug, Oxymetazoline nasal drop (0.05%) and will be advised to instill 2 drops in each nostril in the morning and evening for 7 days. Study will be conducted for 8 days and all observations will be taken and recorded starting from 0th day and follow up will be done 2nd day, 4th day, 6th day and on the 8th day observations will be taken for any recurrences. Data recorded will be analyzed statistically and conclusion will be drawn based on it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting symptoms of Rhinitis (headache,difficulty in breathing,sneezing,redness,nasal discharge and inflammation of nasal mucosa) who are willing to participate will be selected.
排除标准
- •Recently operated patients of nasal surgery, pregnant women or lactating women and those whose age are below 18 yrs and above 60 yrs will be excluded.
结局指标
主要结局
VAS value to decrease in pain by 2-3, number of sneezing to decrease by 2-3 times/days, difficulty in breathing and inflammation of nasal mucosa to decrease from severe to moderate or moderate to mild will be considered as positive effect.
时间窗: 8 days study with 4 follow up (2nd day,4th day,6th day and 8th day)
次要结局
- Reduction in redness, reduction in nasal discharge.(8 days study with 4 follow up (2nd day,4th day,6th day and 8th day))