Therapeutic effects of α- tocopherol and ascorbate on improvement of pulmonary function, cognition and electrophysiological changes in asthmatic patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NA
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Improvements in lung volumes and capacities: FEV1, FVC and PEFR
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Improvements in lung volumes and capacities: FEV1, FVC and PEFR
Time Frame: 12 WEEKS
Secondary Outcomes
- 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)
Investigators
Radhika P
SRM Medical College Hospital and Research Centre