A comparative clinical study to evaluate the efficacy of Shirisharishta and Shirishavaleha in school going children with Pratishyaya (Allergic rhinitis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The proposed study is a randomized, open-label comparative clinical trial evaluating the efficacy of two Ayurvedic formulations—Shirisharishta and Shirishavaleha—in the management of Pratishyaya (allergic rhinitis) in school-going children aged 6–16 years. The study is being planned due to the high prevalence of Allergic Rhinitis in children and its impact on growth and quality of life, linking the condition with Ayurvedic concepts such as Vata-Kapha predominance and Gara Visha (Allergens). Shirisharishta and Shirishavaleha will be given to trial and comparator groups respectively consisting 20 subjects each for a period of 28 days in a pre decided dosage as per age. Assessment will be done based on the changes in the subjective parameters like TNSS Scale and Quality of life on 0th, 3rd, 7th, 14th, 21st and 29th day and Absolute Eosinophil counts before and after the trial. Statistical analysis of the data will be done post trial from which conclusion of the study will be drawn.
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 16.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children aged between 6 to 16 years will be selected irrespective of gender,religion & socioeconomic status.
- •2.Children fulfilling diagnostic criteria of Allergic rhinitis.
- •3.Children whose parents are willing to give informed assent.
排除标准
- •1.Known cases of systemic disorder which may interfere with course of study 2.Known cases of any congenital anomalies which may interfere with course of study 3.Children who are on any other anti-allergic medications 4.Subjects with Nasal polyp, Epistaxis.
研究者
Dr Nagre Pratik Subhash
JSS Ayurveda Medical College
