An open label non comparative prospective clinical trial on the efficacy of BalRasayana syrup as an immunomodulator and its role in recurrent respiratory tract infections in children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in symptoms of respiratory tracrt infections cough cold immunomodulation frequency of cough cold nasal discharge fever
研究概览
简要总结
This study an open label non comparative and prospective trial will be conducted to evaluate the efficacy and safety of Balrasayana syrup doses decided according to age and weight of chilldren in 3 to 16 years as an immunomodulator and its role in recurrent respiratory tract infections primary outcome measures will be improvement in symptoms of respiratory tract infections at 6 weeks the secondary outcome will be improvement in time recovery and hospitalisation during the treatment phase at 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed as suffering from Vataja Pratishyaya on Ayurvedic parameters Age group of 3 to 16 years.
- •Cardinal features of recurrent respiratory tract infections History of at least 3 episodes in the last six months.
排除标准
- •Individuals below 3 years and above 16 years Severe and Complicated respiratory allergic disorders like Bronchitis Pneumonia Tuberculosis Emphysema Lung abscess Bronchiectasis Patients who are diagnosed as Chronic asthma Nasal polyposis Congenital anomalies related to the respiratory system Patients on inhaled or systemic steroids Patients who are suspected of any of the diseases mentioned in exclusion criteria on the basis of history and examination will be excluded.
结局指标
主要结局
Improvement in symptoms of respiratory tracrt infections cough cold immunomodulation frequency of cough cold nasal discharge fever
时间窗: 6 weeks
次要结局
- Improvement in laboratory parameters improvement in hospitalization during treatment phase(12 Weeks)
研究者
Dr Shubhangi Thakur
R A Podar medical college AYU Worli Mumbai
