Study on the Efficacy of Pratishyayahara Vati on Vataja Pratishyaya, Allergic Rhinitis in Children - An Open Label Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in the clinical symptoms of Vataja Pratishyaya based on
研究概览
简要总结
An open label randomised controlled clinical trial on the efficacy of Pratishyayahara vati on Vataja Pratishyaya, allergic rhinitis in children of age group 6-12 years for a period of 15 days. During this study period, 40 children will be recruited and divided into two groups, Group A (Trial drug) and Group B (Control drug), 20 children each. Group A(Trial drug) children will be administered Pratishyayahara Vati (500mg BID AF) and Group B(Control drug) children will be administered Tryushanadi Vati (500mg BID AF) for a period of 15 days. Clinical assessment will be done for both subjective & objective criteria on 0th day, 7th day & 15th day. Statistical analysis will be done through data obtained on 0 day(BT) and 15th day(AT).
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age group of 6 to 12 years fulfilling the diagnostic criteria, irrespective of gender, religion, socio economic status.
- •Children with clinical features of Vataja Pratishyaya with duration less than 15 days.
排除标准
- •Children of age below 6 years and above 12 years.
- •All other types of Pratishyaya, except Vataja Pratishyaya.
- •Children suffering from any chronic debilitating or infectious diseases like Deviated Nasal Septum, Nasal polyp, Sinusitis, fever(temp more than 100F), Tuberculosis, COPD, Congenital lung and cardiac anomalies etc which may interfere with present clinical trial.
结局指标
主要结局
Reduction in the clinical symptoms of Vataja Pratishyaya based on
时间窗: Baseline, 15 days
1. Vataja Pratishyaya Gradation index.
时间窗: Baseline, 15 days
2. TNSS (Total Nasal Symptom Score-Questionnaire)
时间窗: Baseline, 15 days
次要结局
- Significant clinical relief in signs and symptoms of Vataja pratishyaya based on(1. RCAT (Rhinitis Control Assessment Test))
研究者
Dr Meghana S K
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore