Randomised controlled clinical trial on efficacy of darvyadi kashay in tundikeri with special refrence to tonsillitis in children age group 6 to 12 years
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to reduce the swelling of the tonsils,
研究概览
简要总结
OBJECTIVES
primary Objective
- To study efficacy of darvyadi kashay in tundikeri w.s.r to tomsillitis in children of age group 6 to 12 years
2.to study the efficacy of betadine povidine iodine 2% w/v in tujdikeri w.s.r to tonsilltis in children of age group 6 to 12 years
3 to compare the efficacy of darvyadi kashay with betadine gargle in management of tundikeri w.s.r to tonsillitis in children with age group 6 to 12 years
Participant
6 to 12 years children with tundikeri tomsillitis meeting inclusion and exclusion criteria from opd and ipd of department of kaumarbhritya of shree saptshrungi ayurved mahavidhyala and hospital nashik
Intervention
30 patients vachadi kashay syrup- administer as per standard protocol
30 patient betadine gargles administer according as per standard protocol
Primary outcome- to reduce the sign and symptoms of tundikeri
Secondary outcome- no recurrency of tundikeri
Treatment duration- 7 days
Follow up : 0th, 4th, 7th days
Data analysis- Data will be analysed using approprite statistical methods to study the efficacy of vachadi kashay on primary and seconadary outcome.
Ethical consideration- the study will be comducted in accordance with ethical guideline and with informed consent from participants.
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1patients presenting with two or more symptoms like kanthshotha todavatvedana ragatva asyavairasya galoprodha as described in the context of tundikeri 2 children of age group 6 to 12 years either gender irrespective of caste and religion 3 chronic and recurrent tonsillitis.
排除标准
- •1patient suffering from infectious disease 2 patient with peritonsillar abscess tonsillar cyst and tonsillolith will be excluded 3 patient with known case of HIV TB and hepatitis B will be exclude.
结局指标
主要结局
to reduce the swelling of the tonsils,
时间窗: as follow up are set within 7 days, we will observe the patient for the above mentioned complaints and signs
to reduce the pain while swallowing,to reduce the throat congestion, to reduce the redness and uneasiness feeling in the thorat and to reduce the recurrecy of the tonsillitis in age group 6 to 12 years
时间窗: as follow up are set within 7 days, we will observe the patient for the above mentioned complaints and signs
次要结局
- in secondary outcome the recurrency & the signs & symptoms like pain while swallowing should be reduced & the severeness also reduce this is secondary outcome of the trial(7 days)
研究者
DrRavikiran Chhabilal Deore
Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik