Efficacy of kapithashtaka choorna in comparison to nasomac-f nasal spray in kantha shaluka, adenoid enlargement in children - An open labelled randomized controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relieving clinical features and significant improvement of Adenoid Enlargement with subjective symptomatic grading for mouth breathing, snoring, sleep disturbance and otological infection which will be assessed before treatment, 14th day, 28th day and 42nd day
研究概览
简要总结
Efficacy of kapithashtaka choorna in comparison to nasomac-f nasal spray in kantha shaluka, adenoid enlargement in children - an open labelled randomized controlled clinical trial. Minimum 30 children attending outpatient department and inpatient department of Kaumarabhritya of Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru who are fulfilling the inclusion criteria and willing to participate in the study under the parental assent or consent will be recruited for study for a period of 42 days. 30 children will be randomly divided into 2 groups namely Group A (15 children) and Group B (15 children). Group A (Study group) will be administered with Kapithashtaka Choorna in a dose of 2.5g for 3-6 years and 4.5g for 7-10 years with Takra as anupana after food twice daily.
Group B (Control group) will be administered with Nasomac-F nasal spray in a dose of 50mcg for 3-6 years and 50mcg for 7-10 years 1 spray twice daily. Assessment will be done using Lateral X-ray of nasopharynx or nasal endoscopy. Statistical analysis will be done by considering the data of 0 (BT) 14 (monitoring) 28 (AT) and day 42 (follow up) by using suitable test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children of age group 3-10 years of either sex who fulfills the diagnostic criteria.
- •2.Willing to participate under parental consent.
排除标准
- •1.Children below 3 years and above 10 years will be excluded.
- •2.Children suffering from nasal polyp, nasal bleeding will be excluded.
- •3.Children having anatomical anomalies like nasal septum deviation, craniofacial malformation including cleft lip, cleft palate, hypersensitivity to drugs.
- •4.Children with previous adenoidectomy cerebral palsy, genetic syndrome, ear discharge, tympanic membrane (TM) perforation, and congenital ear deformities.
- •5.Children suffering from other systemic illness will be excluded.
结局指标
主要结局
Relieving clinical features and significant improvement of Adenoid Enlargement with subjective symptomatic grading for mouth breathing, snoring, sleep disturbance and otological infection which will be assessed before treatment, 14th day, 28th day and 42nd day
时间窗: 42 days
次要结局
未报告次要终点
研究者
Dr Jadhao Uday Bhaskar
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore, Karnataka