Randomized Controlled Clinical Study To Evaluate The Efficacy Of Dronapushpi Arka Nebulization In Tamakashwasa With Special Reference To Bronchial Asthma In Children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To clinically evaluate and compare the efficacy of Dronapushpi Arka and Parnayavani Arka nebulization in the management of Tamaka Shwasa (Bronchial Asthma) in children, based on the outcomes assessed through GINA (Global Initiative for Asthma) scoring.
研究概览
简要总结
Children are among the most vulnerable groups in society and need special care. Bronchial asthma is a common non-communicable disease that affects both children and adults. It is the most frequent chronic illness in children. Asthma is marked by episodes of breathing difficulty caused by airway inflammation and blockage, which is usually reversible.
Out of 200 million asthma patients worldwide, about 15 million are in India. In Indian children aged 5–11 years, the estimated asthma rate is 10% to 15%. Moderate to severe cases need daily treatment with long-term medicines (like anti-inflammatory drugs) to manage inflammation and prevent symptoms. Inhaled short-acting medicines are used to relieve sudden symptoms.
A major breakthrough in modern treatment is inhalation therapy, using drugs like Salbutamol and corticosteroids via nebulizers or aerosols. Inhaled medicine works fast because the lungs absorb it quickly, providing quick relief.
However, modern medicines often cause side effects and may not be ideal for long-term use. In Ayurveda, Bronchial Asthma is similar to "Tamaka Shwasa," a Vata-Kaphaja disorder with symptoms like labored breathing, cough, and wheezing. Herbal treatments (phyto-medicines) are becoming popular again due to their safety and effectiveness, as shown in clinical studies.
There is a need to develop Ayurvedic inhalation therapies that are safe, effective, and suitable for daily use. Herbs with properties like pungent (Katu), bitter (Tikta) taste, hot potency (Ushna Virya), and volatile nature are useful for nebulization. Dronapushpi and Parnayavani have these qualities. They help clear airways by reducing Kapha and supporting Vata balance.
Studies show these herbs contain volatile oils with strong bronchodilator effects. Using them as a distillate (Arka) in nebulization may benefit children with Tamaka Shwasa. This study focuses on evaluating the effectiveness of Dronapushpi Arka nebulization in such cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 11.00 Year(s)（—）
入选标准
- •Children Of Age Group 6-11 Years, Irrespective Of Gender, Religion And Socio Economic Status Will Be Included.
- •Children With Mild To Moderate Exacerbations Of Asthma Will Be Included.
- •Children Whose Parents Are Willing To Sign The Written Consent Form Will Be Included.
排除标准
- •Children With Severe Exacerbations Of Asthma Will Be Excluded.
- •Children With Known Case Of Tuberculosis, Emphysema, COPD Will Be Excluded.
结局指标
主要结局
To clinically evaluate and compare the efficacy of Dronapushpi Arka and Parnayavani Arka nebulization in the management of Tamaka Shwasa (Bronchial Asthma) in children, based on the outcomes assessed through GINA (Global Initiative for Asthma) scoring.
时间窗: 0TH day,7TH day,9TH day
次要结局
- 1.To Do A Detailed Literary Review Of Tamaka Shwasa.(2.To Monitor The Adverse Drug Reaction.)