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临床试验/CTRI/2023/01/048667
CTRI/2023/01/048667尚未招募不适用

Effects of combined yoga therapy with breathing exercises versus breathing exercises alone on the pulmonary function test parameters in mild to moderate bronchial asthma patients taking standard care treatment: a randomized control trial.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Improvement in Pulmonary Function Test parameters

研究概览

简要总结

Patients with Mild to Moderate severity of Bronchial Asthma will be recruited from Pulmonology OPD of JIPMER, Puducherry after meeting the inclusion and exclusion criteria. After obtaining informed written consents, participant’s Pulmonary Function Test parameters will be recorded in Physiology Department in the morning after which 5ml of fasting venous blood sample will be taken. Following the blood sample collection Participants is allowed to have light breakfast. The Participants are Randomly allocated one of the groups among the three groups of this study using a random sequence generated by a computer. The participants falling under first group will be called back after 12 weeks to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The participants falling under second group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist every alternate day in the first week of the study following which they will continue doing the Physiotherapy exercises at home daily for a period of 11 weeks. The participants falling under third group will be sent to the Pulmonology Department for learning Physiotherapy exercises from Physiotherapist and to the Yoga Centre in Physiology department to learn Yogasanas and Pranayamas from trained Yoga Instructors every alternate day in the first week of the study period after which they will be asked to practice the Physiotherapy exercises and Yogasanas at their home daily for a period of 11 weeks. After a period of 12 weeks from the start oif the study, all the participants from second and third group will also be called back to the Physiology Department for recording Pulmonary Function Test parameters and collecting 5ml of venous blood sample. The changes in Pulmonary Function Test parameters and venous blood before and after intervention will be compared. All the Participants will be requested to Fill 2 Questionnaires at the beginning of the study and after 3 months of the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Mild to Moderate severity of Bronchial Asthma patients of either gender of age group 20-60years on standard care treatment, visiting JIPMER Pulmonology OPD for treatment will be included in this study.

排除标准

  • Severe asthma patients, patients already practicing yoga, breathing exercises or regular physical activity, patients with uncontrolled hypertension on drugs, patients with diabetes mellitus, pregnant females, participants with endocrine diseases requiring steroid treatment (rheumatoid arthritis, multiple sclerosis, Addison’s disease, systemic lupus erythematosus, inflammatory bowel disease), participants with severe obesity.

结局指标

主要结局

Improvement in Pulmonary Function Test parameters

时间窗: 2 time points: At baseline and after 3 months.

次要结局

  • 1. IL-4(2. IL-5)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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