Therapeutic effects of α- tocopherol and ascorbate on improvement of pulmonary function, cognition and electrophysiological changes in asthmatic patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Improvements in lung volumes and capacities: FEV1, FVC and PEFR
研究概览
简要总结
Previous literature shows that severe asthma causes cognitive dysfunction, decline in lung function, cardiovascular changes and even known to cause seizures altering EEG. Ascorbate and alpha- tocopherol due to its antioxidant and anti- inflammatory properties can potentially benefit in managing the complications in asthmatics. Existing studies provide least evidences about the therapeutic role of these vitamins in improving cognition, pulmonary function and electrophysiological changes in asthmatics, so the present study has been designed to evaluate the prognostic effect of alpha- tocopherol and Ascorbate, which can be a sort of natural, less toxic, readily available dietary supplement to improve quality of life in asthmatics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Known case of asthmatic patients of all severity (mild intermittent, mild persistent, moderate, severe persistent) visiting the OPD
- •Willing participants
- •Agree to continue use of vitamin supplements for the duration of the study.
排除标准
- •Subjects having CNS related disorders including neurodegenerative conditions and epilepsy
- •Patients with history of cardio-vascular dysfunction, other pulmonary dysfunctions, myopathies and ocular diseases
- •Patients with coagulation defects and are on anticoagulant therapy
- •Pregnant and lactating mothers
- •Patients routinely following yogic practices like pranayama.
结局指标
主要结局
Improvements in lung volumes and capacities: FEV1, FVC and PEFR
时间窗: 12 WEEKS
次要结局
- Improvements in the recorded ECG, EEG, EMG, EOG & EDA changes ,IF PRESENT during pre- intervention(12 weeks)
- Improvement in cognition score out of 100(12 weeks)
研究者
Radhika P
SRM Medical College Hospital and Research Centre