Preclinical and Clinical evaluation of the Safety and efficacy of Thippili Rasayanam in the treatment of Iraippu Noi (Childhood Asthma) in children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Efficacy of the trial drug is measured by Spirometry test (FEV1) on 0th,22th and 40th day treatment and improvement in the clinical condition will be determined through in this data.
研究概览
简要总结
This study aims to evaluate the safety and efficacy of Thippili Rasayanam in children with asthma.Patients are enrolled in this study based on the inclusion and exclusion criteria. A diagnosis of Childhood Asthma will be provisionally diagnosed in patients with recurrent cough, wheeze, tightness of chest, difficulty in breathing, and will be confirmed using objective measures of Spirometry test. The trail drug Thippili Rasayanam as internal medicinewill be given for 40 days and the patient will be requested to attend the OPD once in 7 days for 40 days. Changes in the clinical symptoms will be recorded by Asthma control Questionnaire at each visit. This study will be evaluated by using Spirometry test for Iraippu noi (Childhood Asthuma) on pre and post treatment. After the completion of the treatment, the patient is advised to visit our OPD for follow up for three months.
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
- •Children aged 6 years and 12 years old at time of giving consent
- •Children with symptoms of Wheezing, Cough, difficulty in breathing, Tightness of Chest as per IAP 2022 Asthma guidelines
- •History of wheezing more than three episodes in a year.
- •Willing to sign consent and assent forms.
- •Patient willing to attend the OPD once in 7 days for 40 days.
排除标准
- •Any other lung disease other than Asthma.
- •Patients unable to perform Spirometry test.
- •Patients who are in the process of another clinical research.
- •Children with any other active systemic illnesses.
结局指标
主要结局
• Efficacy of the trial drug is measured by Spirometry test (FEV1) on 0th,22th and 40th day treatment and improvement in the clinical condition will be determined through in this data.
时间窗: Pre-treatment, post-treatment (40 days), and follow-up (3 months)".
• Changes in the clinical symptoms will be recorded by Asthma control Questionnaire at each visit (Once in 7 days) for 40 days.
时间窗: Pre-treatment, post-treatment (40 days), and follow-up (3 months)".
次要结局
未报告次要终点
研究者
SHALINI B
National Institute of Siddha