FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072806 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Benefits of Vitamin E and Vitamin C on Lung Function Cognition and electrical activities in Asthma Patients  
Scientific Title of Study   Therapeutic effects of α- tocopherol and ascorbate on improvement of pulmonary function, cognition and electrophysiological changes in asthmatic patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Radhika P 
Designation  Tutor and PhD scholar 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Physiology, Ground floor, Room No. 8, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu District, Tamil Nadu

Chennai
TAMIL NADU
603203
India 
Phone  9539599256  
Fax    
Email  radhikap1@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Thamarai Selvi K 
Designation  Professor, Department of Physiology 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu District, Tamil Nadu

Chennai
TAMIL NADU
603203
India 
Phone  9840635457  
Fax    
Email  thamarak@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Radhika P 
Designation  Tutor and PhD scholar 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Physiology, Ground Floor, Room No. 8,SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu District, Tamil Nadu

Chennai
TAMIL NADU
603203
India 
Phone  9539599256  
Fax    
Email  radhikap1@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM MEDICAL HOSPITAL AND RESEARCH CENTRE,SRM Nagar, Potheri, Kattankulathur, Chengalpattu District,Tamil Nadu, India. 603203 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Thamarai Selvi K  SRM Medical College Hospital  Room No. 12, Research Lab, Department of Physiology, Ground Floor
Chennai
TAMIL NADU 		 9840635457

thamarak@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ascorbate and alpha tocopherol  1000mg and 500mg- orally administered once for 12 weeks 
Comparator Agent  Placebo  Once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Known case of asthmatic patients of all severity (mild intermittent, mild persistent, moderate, severe persistent) visiting the OPD
2. Willing participants
3. Agree to continue use of vitamin supplements for the duration of the study
 
 
ExclusionCriteria 
Details  1. Subjects having CNS related disorders including neurodegenerative conditions and epilepsy
2. Patients with history of cardio-vascular dysfunction, other pulmonary dysfunctions, myopathies and ocular diseases
3. Patients with coagulation defects and are on anticoagulant therapy
4. Pregnant and lactating mothers
5. Patients routinely following yogic practices like pranayama
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvements in lung volumes and capacities: FEV1, FVC and PEFR  12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
Close