A comparative clinical study on the efficacy of Bharangimoola arka and Tamboola patra arka nebulization in the management of Tamaka swasa in children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Parameters: Spirometry and Peak Expiratory Flow Rate
研究概览
简要总结
The prevelance of respiratory disorders like Tamaka swasa is observed to be predominant in the early childhood. Tamaka swasa can be closely related to asthma owing to the similarity in the presenting features which includes wheezing, cough, chest tightnesss, difficulty in breathing and in severe cases disturbance to the day-to-day activities. Children are more prone to the respiratory disorders owing to the reduced immunity, hereditary factors or other external environmental factors like dust, pollen, pollution etc.
Nebulization is a method which has been in use for relieving the symptoms of the asthma attack. It involves suspension of fine vaporised liquid directly into the respiratory system and hence relieving the bronchospasm involved. Regular use of the modern medicines for nebulisation is found to have some adverse reactions. Hence, this study involves the suspension of the liquid extract of the drugs Bharangi (*Clerodendrum serratum)*and Tamboola (Piper betel) for the management of Tamaka swasa.
References of the drugs in possessing swasahara property have been explained widely in our classics. Both the drugs possesses katu tikta rasa, laghu ruksha guna and ushna virya which effectively alleviates and clears the vitiated kapha lodged in the pranavaha srotas, and channelizing the normal gati of vata. Thus, the symptoms of swasa is relieved.
This study involves the administration of Bharangi moola arka and Tamboola patra arka for children affected with the lakshanas of Tamaka swasa in the age group of 8-12 years. One group, consisting of 15 patients will be administered with Bharangi moola arka and the other group with Tamboola arka. 3ml of the medicine will be used 8th hourly for 2 days in the patients. Assessment of the treatment will be based on GINA assessment criteria and the spirometry and PEFR done before and after the administration of the medicine.
Statistical analysis of the study data will be performed using statistical software SPSS 20.0, unpaired t test and Wilcoxon test will be carried out for within the group analysis, paired t test and Mann Whitney for between the group analysis along with Repeated Measure ANOVA test.
The present study taken aims to provide an insight into the concept of Tamaka swasa based on the classical references and allied modern literature to study and document the comparative efficacy of the drug Bharangi and Tamboola in the form of arka for nebulization during the vegavastha of Tamaka swasa in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Children of age group 8-12 years, irrespective of gender, religion and socio-economic status.
- •Children with mild to moderate exacerbation of asthma.
- •Parents who are consciously willing to participate their children in the study and ready to sign the informed assent form.
排除标准
- •Children with H/o or presenting with tuberculosis, emphysema, chronic airway limitation, severe upper airway obstruction or any anatomical defect in airway.
结局指标
主要结局
Objective Parameters: Spirometry and Peak Expiratory Flow Rate
时间窗: 2 days
Subjective parameter as per GINA assessment criteria(2015) in which alertness, respiratory rate, pulse, wheeze, breathlessness, position, sputum, talk and tightness of chest are assessed as mild, moderate and severe.
时间窗: 2 days
次要结局
- Overall health improvement
