Clinical Study on the Immunomodulatory Effect of Nidigdhikadi Leha on Pranavaha Srotodushti w.s.r Upper Respiratory Tract Infections in Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Morbidity Score
研究概览
简要总结
Children have a speedy physical &psychological changes undergo from birththrough adolescence. The process of childdevelopment can include everything fromsensory awareness & fine motor skills.Children have a greater variety of acutechronic problem. Preventable diseases such aspneumonia, diarrhoea & other infections aremajor cause of child’s morbidity so allchildren have varying physical and emotionalneeds, depending on their age, personality anddevelopmental stage. The immune system hasinvolved dealing with infections pathogens.This refers to the ability of body to defend.Itself against specific invading agents such asbacteria, toxins, viruses and foreign bodytissues. The immune system can be broadlydivided into 2 categories, innate and adaptiveimmunity. Innate immune cells are found inrelative abundance throughout the body andinclude neutrophils, basophils, mast cells,eosinophils, monocytes, macrophages anddandritic cells. The adaptive immune systemincludes T and B lymphocytes. Typically,patients who have immune deficiencies inadaptive immunity in the setting of recurrentrespiratory tract infection have deficiency inadaptive immunity or dysfunction in either Bor T cells leads to poor antibody production orquality and subsequent susceptibility tosinopulmonary infections. Epidemiologistestimates that 15% of children suffers fromRRTIs, Among the predisposing factorsimmune system deficiencies can be consideredas well as anatomic and functional alteration in the respiratory tract, air pollution exposure orpoor social conditions. RRTI are a commonproblem mainly in preschool age, usually dueto unfavourable environmental conditions.RRTIs initially occur as a viral respiratory tractinfection, but bacterial growth is demonstratedin 60% of patients with symptoms of an upperrespiratory tract infection of at least 10 daysduration. Therefore with these perspectives thepresent trial entitled “Clinical Study on theImmunomodulatory Effect of NidigdhikadiLeha on Pranavaha Srotodushti w.s.r. UpperRespiratory Tract Infections in Children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 6 to 12 years of either sex.
- •Children with recurrent upper respiratory infections.
- •Children whose parents are willing to give consent for clinical trail.
排除标准
- •Children suffering from major systemic illness necessitating hospitalization.
- •Children with evidence of malignancy, genetic or congenital anomaly.
- •Children with concurrent serious hepatic dysfunction (defined as AST and/or ALT>3 times of the upper normal limit) or renal dysfunction (defined as S.
- •creatinine>1.2mg/dl) uncontrolled pulmonary dysfunction (asthmatic and COPD patients) 4) Chronic illness like TB, UTI and bleeding disorders etc.
- •H/o hypersensitivity to any of the trial drug or their ingredients.
- •Children who have completed participation in any other clinical trial during the past six months.
结局指标
主要结局
Change in Morbidity Score
时间窗: 8 Weeks
次要结局
- Decrease in episodes of Upper Respiratory Tract Infections(8 Weeks)