Pilot Study to Evaluate the Efficacy of Topical Application of Kadali Kshara on Inferior Turbinate Hypertrophy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Changes in NOSE score from baseline to 15th day.
研究概览
简要总结
The patient diagnosed with inferior turbinate hypertrophy fulfilling inclusion and exclusion criteria attending OPD Shalakya tantra and ENT OPD, S.S.Hospital ,IMS BHU will be assigned into control and trial group by simple randomization. Present pilot study sample size is 15 in trial group and 10 in control group. In the trial group, topical application of kadali kshara was done while in the control group nasal decongestants Xylometazoline oxymetazoline hydrochloride nasal solution was given for 5 days.The patient will be assessed based on subjective and objective parameters and follow up for 7th and 15th day. Subjective parameters will be assessed according to NOSE(Nasal obstruction symptom evaluation) scores - Nasal congestion or stuffiness, Nasal blockage or obstruction, trouble breathing my nose, Unable to get enough air through my nose during exercise or exertion, Trouble sleeping, just before commencing treatment , after treatment and during follow up. Objective parameters include Friedman grading system of inferior turbinate hypertrophy, Nasal endoscopic grading system of inferior turbinate hypertrophy, Laboratory test CBC and ESR and Pictorial presentation of inferior turbinate hypertrophy before treatment and after treatment, assessed on before and after treatment. The data collected will be analysed statistically by using appropriate test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Patients presenting with signs and symptoms of Nasanaha.
- •Patients having ITH.
- •Friedman Grading System of Inferior Turbinate Hypertrophy.
- •Nasal endoscopic grading system of inferior turbinate hypertrophy.
- •Patients ready to sign informed consent form.
排除标准
- •Cases complicated with Nasal Polyposis.
- •Deviated Nasal Septum with Concha bullosa.
- •Age group of below 18 year and above 60year of age.
- •Patient who starts developing complications will be excluded from the study.
- •Patient not willing for the treatment.
- •Ongoing systemic infection.
- •Ear, Nose & Throat malignancy.
- •Congenital deformity.
- •Cases which required surgical intervention.
结局指标
主要结局
1. Changes in NOSE score from baseline to 15th day.
时间窗: Day 0, Day 7, Day 15
2. Friedman Grading System of Inferior Turbinate Hypertrophy from baseline to 15th Day
时间窗: Day 0, Day 7, Day 15
次要结局
- Changes in inferior turbinate hypertrophy size.(Day 0, Day 15)
研究者
Deepak Kumar Verma
Banaras Hindu University
