Randomised clinical trial for determination of efficacy of Gojihvadi syrup and Anu taila nasya in managing childhood allergic rhinitis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in severity score of Allergic rhinitis.
研究概览
简要总结
This study is a randomized comparative interventional parallel group clinical trial comparing the therapeutic efficacy and to evaluate the anti-allergic and immuno-modulatory effect of ANU TAIL NASYA (2 drops daily) with or without GOJIHVADI Syrup daily in doses as per the patient’s age for a period of 6 weeks in 100 patients of Respiratory Allergic Disorder that will be conducted in All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi. The primary endpoint measures will be reduction in the severity score of Allergic rhinitis assessed after 6 weeks of treatment. The secondary endpoint will be changes in the Quality of Life of children in both the groups.
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
- 7.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of Cardinal features of Pratishaya like kasa, Nasa Srava, Ghranoparodha, Gandhagyan, Galashotha, Shwaskashtata, Akshikandu, Sashabdaswaas, Shirahshoola, Jwara, Kshwathu, Swarasada.
- •Recurrence of at least one episode every month for last one year or more.
- •Patients who are willing to participate in the study and come for follow up.
排除标准
- •Severe and Complicated respiratory allergic disorders.
- •Other respiratory infectious conditions such as Tuberculosis, Plural effusion, Emphysema, Lung abscess, Bronchieactasis, pneumonia, Pleurisy.
- •Upper Respiratory complaints such as Nasal polyposis, Nasal tumours.
- •Congenital anomalies of respiratory tract.
- •Children with chronic debilitating diseases like JDM, HIV, HBsAg, immune compromised children etc.
- •Patients who are not willing to be included in the study protocol and also who are not willing to give the consent for the study.
结局指标
主要结局
Reduction in severity score of Allergic rhinitis.
时间窗: Reduction in severity score of Allergic rhinitis.
次要结局
- Changes in the Quality of Life of children in both the groups according to WHO.(at the end of the study)