An open labelled multicentric prospective clinical study to assess the effectiveness of Kumarabharana Rasa in recurrent upper respiratory tract infections with special reference to chronic tonsillitis in children
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi).
研究概览
简要总结
This study is an open labelled multicentric prospective clinical study to assess the effectiveness of Kumarabharana Rasa in recurrent upper respiratory tract infections with special reference to chronic tonsillitis in children. The subjects were given tablets of 500 mg, before food in the morning once a day mixed with honey orally for a period of 60 days on empty stomach. The primary outcome measures will be Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi). The changes in Haemoglobin%, Total leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and Absolute Eosinophil Count will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of both genders between 5-10 years of age, who were suffering from repeated attacks of tonsillitis (chronic) in past year.
- •Those participants whose parents are ready to sign the consent form and allow their children to participate in the clinical trial will be included.
排除标准
- •Patients with acute tonsillitis, peritonsillar abscess, tonsillar cyst, tonsillolith or with any other systemic disorders.
- •Also the patients who have taken systemic steroids and/or antibiotics in the past four weeks.
结局指标
主要结局
Reduction in Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi).
时间窗: 60 days
次要结局
- Changes in Haemoglobin%, Total(leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and)