A randomized controlled clinical study to evaluate efficacy of Dashmuladi Kashaya & Haritaki Kashaya in the management of Tundikeri(chronic tonsillitis) in children.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Kathin shotha(enlarged tonsils)
研究概览
简要总结
Topic name : A randomized controlled clinical study to evaluate efficacy of Dashmuladi Kashaya and Haritaki Kashaya in the management of Tundikeri (chronic tonsillitis)in children.
Study settings : OPD and IPD of Govt Ayurveda college Nanded
Study population : Patients of Tundikeri coming to OPD and IPD of Govt Ayurved College,Nanded
Nature of sample : Pediatric patients of Tundikeri (chronic tonsilliti) of age 5 years to 12 years will be selected after screening of subjects for inclusion.
Sampling size : by randomized sampling technique 50 patients each in Trial and control group. Total 100.
Intervention: Control group - Haritaki kashaya
Trial/Experimental group - Dashmuladi kashaya
Duration of intervention- 15 days
Assessment on Follow ups at 7, 16, 30 th day
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
- 5.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having two or more symptoms of chronic tonsillitis or tundikeri.
- •Patients with chronic tonsillitis except positive throat culture for Group A streptococcus.
排除标准
- •Patients with Quinsy, Tonsillolith.
- •Patients with any other systemic disorder.
- •Patients with positive Group A streptococcus throat culture.
- •Patients below 5 years and above 12 years of age.
结局指标
主要结局
Kathin shotha(enlarged tonsils)
时间窗: at base line at 8th day,16th day and 30th day
Chronic tonsillitis (Tundikeri) cured or not cured on the basis of symptoms and signs.
时间窗: at base line at 8th day,16th day and 30th day
Mand Ruk(sore throat)
时间窗: at base line at 8th day,16th day and 30th day
Picchilata(exudates)
时间窗: at base line at 8th day,16th day and 30th day
Difficulty in swallowing
时间窗: at base line at 8th day,16th day and 30th day
Halitosis
时间窗: at base line at 8th day,16th day and 30th day
次要结局
- Complete blood count
