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CTRI Number  CTRI/2022/04/041902 [Registered on: 19/04/2022] Trial Registered Prospectively
Last Modified On: 02/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of vitamin E on oxidative stress in patients with epilepsy 
Scientific Title of Study   Effect of vitamin E as an add-on therapy on oxidative stress in patients with epilepsy- A randomized placebo controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jefry Winner G 
Designation  Junior resident 
Affiliation  JIPMER 
Address  Department of Pharmacology, JIPMER, Puducherry.
No.4, first street Ramaraja nagar, near Rajaannamalai nagar, Gorimedu Puducherry-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9677694386  
Fax    
Email  jefrywinner0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anusha N 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Department of pharmacology, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9659879322  
Fax    
Email  anushanatarajan29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anusha N 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Department of pharmacology, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9659879322  
Fax    
Email  anushanatarajan29@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural research fund 
 
Primary Sponsor  
Name  JIPMER  
Address  JIPMER Gorimedu Pondicherry-605006 
Type of Sponsor  Research institution and hospital 
 
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 
Anusha N  JIPMER  JIPMER Hospital Department of Neurology Room no:209 Puducherry 6050006
Pondicherry
PONDICHERRY 		 9659879322

anushanatarajan29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G409||Epilepsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  starch capsules 400mg  These will be given similar to the intervention agent 
Intervention  Vitamin E capsules 400mg  These will be given for a period of 6months twice daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1.Adult patients of age ≥18 to ≤60 years of either gender.
2.Patients on Monotherapy with sodium valproate, Phenytoin, carbamazepine for at least a period of 6 months.
3.Patients with uncontrolled seizure (defined as having a seizure episode at least one per year when maintained on an adequate trial of antiepileptics)
 
 
ExclusionCriteria 
Details  1. Patients with other comorbidities like renal diseases and liver diseases
2. Patients already on treatment with Vitamin E.
3. Patients with structural brain diseases and space occupying lesions as diagnosed on appropriate imaging
4. Patients not willing to give written informed consent
5. Pregnant and lactating women

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
primary objectives
1.To estimate the changes in antioxidant levels and oxidative stress markers in patients receiving vitamin E as add-on therapy and its impact on seizure free interval when compared with placebo

 		 Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the EEG changes between both groups  This will be done at baseline and at 6 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   25/06/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   As of now still the study havent commenced yet, the details regarding publication will be updated later 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1.   Epilepsy is one of the most common neurological disorders worldwide. With numerous treatment options the need for antiepileptics for a long term in many patients makes their quality of life distressing. One of the profound mechanisms is due to oxidative stress that plays a major role in development and progression of epileptogenesis. This can be combated by vitamin E an antioxidant Vitamin which shows effective reduction in seizure frequency and oxidative stress as evidenced from previous literature. The novelty of this study lies in the fact that Indian population has inherently high oxidative stress which is due to higher homocysteine levels in blood contributed by various genetic and dietary factors. This study uses this property of vitamin E to modify the course of disease in patients with epilepsy.

 
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