EFFECT OF CYCLIC MEDITATION ON PULMONARY FUNCTION AND PSYCHOLOGICAL PARAMETERS IN PATIENTS WITH BRONCHIAL ASTHMA - A RANDOMIZED CONTROLLED TRIAL.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- forced expiratory volume in one second (FEV1)
研究概览
简要总结
This study presents a randomized controlled trial evaluating the effects of cyclic meditation (CM) on pulmonary function and psychological parameters in 104 adults (19 to 50 years) with bronchial asthma, a widespread respiratory disease causing airway inflammation and significant morbidity globally and in India. Given the limitations of conventional pharmacotherapy, including inhaled corticosteroid side effects, CM a meditation practice based on the Mandukya Upanishad, offers potential benefits by enhancing vagal tone, reducing stress, and improving lung function, supported by prior research. Study participants with ACQ 6 scores more than or equal to 1.5 and 2 to 6 exacerbations per year, excluding those with major comorbidities and smokers, will be randomized to either a CM intervention group or control. The CM intervention consists of 35 to 40 minute sessions, for four weeks. Primary outcomes include pulmonary function tests (FVC, FEV1, FEV1/FVC ratio, PEFR), while secondary outcomes assess sleep quality (PSQI) and anxiety (HAM A). The study aims to establish CM as a beneficial complementary therapy in bronchial asthma management
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
- 19.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •Age between 19 to 50 years.
- •Gender of Both male and female subjects
- •2 to 6 exacerbations in the previous year
- •Patients with a history of asthma or other typical clinical symptoms associated with respiratory issues
- •Asthma control questionnaire, ACQ 6 score more than or equal to 1.5 atleast twice throughout the screening
- •People with asthma of any duration, severity, and ethnicity.
- •Willingness to participate in the study.
排除标准
- •Evidence of comorbidities like HIV and AIDS.
- •Presence of psychiatric co morbidity.
- •Other neurological diseases.
- •Other serious systemic illness, e.g. hepatic, renal, cardiac or CNS major psychiatric illness
- •Valvular diseases and respiratory disorders like Bronchiectasis, Cystic fibrosis, and Pneumothorax
- •Smoker within the past 6 months.
- •Recent surgery.
- •Patients participating in other studies.
结局指标
主要结局
forced expiratory volume in one second (FEV1)
时间窗: Pre, Post
Their ratio (FEV1/FVC)
时间窗: Pre, Post
Peak expiratory flow rate (PEFR)
时间窗: Pre, Post
Pulmonary function tests(PFTs)
时间窗: Pre, Post
forced vital capacity (FVC)
时间窗: Pre, Post
次要结局
- 1. Pittsburgh Sleep Quality Index (PSQI)(2. Hamilton Anxiety Rating Scale (HAM-A))
研究者
Dr Ashwini A
SDM College of Naturopathy and Yogic Sciences