Effect of Yoga Therapy on Suppressor of Cytokine Signaling (SOCs) Gene Expression in Children with Asthma: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Primary outcome for this trial will be the change in gene expression level of Supression of Cytokine Signalling(SOCS) gene 1,3,5 in children with bronchial asthma
研究概览
简要总结
Asthma is a chronic respiratory condition with an estimated prevalence of about 7.9% and 9.1% of the pediatric population in India and globally respectively. Pharmacological treatment for asthma significantly impairs the quality of life and is also associated with several comorbidities such as nausea, fever, bronchospasm, vomiting, headache, pain, dizziness, cough, allergic reaction, dry mouth, sweating, etc. based on available literature it is found that Suppressor of Cytokine Signalling (SOCS) play a pivotal role in regulating excess cytokine signaling that is responsible for chronic inflammation in bronchial asthma. Interventions similar to the yoga modality such as pulmonary rehabilitation and sequential inspiratory muscle exercise found a significant impact on pulmonary function and exercise capacity by modulating SOCS JAK-STAT pathway in patients with different pulmonary disorders such as COPD and cystic fibrosis. To know the mechanistic pathway involved in improving pulmonary functions by yoga therapy in asthma this study is designed as a Randomized Controlled Trial with the primary objective is to to analyzing the gene expression of SOCS1,3,5 in peripheral blood mononuclear cells (PBMCs) using qRT-PCR in children with asthma undergoing 12 weeks of yoga therapy. The secondary objective for this study is designed as follows
- To assess the efficacy of yoga therapy in improving asthma symptoms using ACT and overall quality of life using PAQLQ in children with asthma undergoing yoga therapy versus those who receive standard care.
- To evaluate changes in lung function parameters, including FEV1 and PEFR in children with asthma undergo yoga therapy intervention versus who receives standard care.
- To evaluate the changes in blood eosinophil count in children with asthma who undergo yoga therapy versus those who receive only standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged between 7 and 18 years of either gender With a minimum bronchial asthma history for more than 6 months diagnosed through the Global Initiative for Asthma guideline for chronic bronchial asthma.
排除标准
- •If patients have any concomitant pulmonary disease or any other systemic disease.
- •If patients suffering from Contraindications to yoga and exercise testing If patients have a history of recent major surgery If patients are participating in any other trial, receiving any additional complementary therapy Participant practicing structured yoga before the recruitment in the study.
结局指标
主要结局
Primary outcome for this trial will be the change in gene expression level of Supression of Cytokine Signalling(SOCS) gene 1,3,5 in children with bronchial asthma
时间窗: Time point for primary outcome assessment will be 0 week for baseline and 12 weeks for post intervention assesment
次要结局
- 1. To assess the efficacy of yoga therapy in improving asthma symptoms using ACT and overall quality of life using PAQLQ in children with asthma undergoing yoga therapy versus those who receive standard care.(Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment)
- To evaluate changes in lung function parameters, including FEV1, FVC and PEFR in children with asthma undergo yoga therapy intervention versus who receives standard care.(Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment)
- To evaluate the changes in blood eosinophil count and IgE level in children with asthma who undergo yoga therapy versus who receives only standard care.(Time point for assessment will be 0 week for baseline and 12 weeks for post intervention assesment)
研究者
Prof Meenu Singh
AIIMS Rishikesh