RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO ASSESS THEEFFECT OF HINGVADI TAILA KARNAPOORAN IN KARNASHOOLA W.S.R.DIFFUSE OTITIS EXTERNA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction of pain in ear
研究概览
简要总结
This is a randomized, parallel-group, open-label, active-controlled trial for assessing the efficacy of Hingvadi taila karnapooran in karnshoola w.s.r. to diffuse otitis externa over another ayurvedic formulation shrungberadi taila in 60 patients, that will be conducted in one center in India. Patients irrespective of gender, occupation and economical class with the age ranging in between 18 to 60 will be selected for the trial by random allocation. Karnapoorana will be done daily for 15 days in which the assessment will be done on 5th,10th, 15thand 30thday of treatment.
The primary outcome measures will be; reduction of pain in ear at 15 days. Secondary outcomes will be; reduction in itching and burning sensation if any.
The conclusion will be drawn based on outcomes and result will be generated accordingly with the help of statistical findings
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
- •Patient having sign and symptoms of Karnashoola.
- •Unilateral of Bilateral diffuse otitis externa.
- •Intact tympanic membrane.
排除标准
- •Patients having any other karnarogas like Karnaguthak,Karnastrav.
- •Patient having any other ear diseases than Diffuse otitis externa.
- •Patient having any systemic disease expect hypertension.
- •Congenital anomalies of the ear.
结局指标
主要结局
reduction of pain in ear
时间窗: 30 days
次要结局
- reduction of burning and itching sensation if any..(30 days)