| CTRI Number |
CTRI/2010/091/000228 [Registered on: 30/04/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
|
RISK OF SEIZURE RECURRENCE IN PATIENTS WITH NEW ONSET PARTIAL SEIZURE: A COMPARATIVE STUDY BETWEEN PATIENTS HAVING SOLITARY CYSTICERCUS GRANULOMA AND THOSE WITH NORMAL NEUROIMAGING |
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Scientific Title of Study
|
RISK OF SEIZURE RECURRENCE IN PATIENTS WITH NEW ONSET PARTIAL SEIZURE: A COMPARATIVE STUDY BETWEEN PATIENTS HAVING SOLITARY CYSTICERCUS GRANULOMA AND THOSE WITH NORMAL NEUROIMAGING |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Sharma |
| Designation |
|
| Affiliation |
|
| Address |
department of neurology
CSM Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
drpawan_sharma@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prof R.K.GARG |
| Designation |
|
| Affiliation |
|
| Address |
department of neurology
CSM Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
garg50@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
prof R.K.GARG |
| Designation |
|
| Affiliation |
|
| Address |
Department of neurology
CSM Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222257090 |
| Fax |
05222257090 |
| Email |
garg50@yahoo.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
|
| Name |
none |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof R.K GARG |
Department of neurology |
Department of neurology ,CSM MEDICAL UNIVERSITY-226003
Lucknow
UTTAR PRADESH |
05222257090
05222257090
garg50@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,CSMMU,LUCKNOW |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
epilepsy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
not applicable |
not applicable |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
The patients of new onset partial seizure of <2 week duration with CECT brain showing solitary cystic granuloma or normal neuroimaging including MRI BRAIN WITH GAD |
|
| ExclusionCriteria |
| Details |
the patientswho had received anticysticidal therapy such as albendazole or steroid. the patients fitting in benign epilepsy syndrome such as benign rolandic epilepsy |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| seizure recurrence |
6 month |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| death |
6 month |
|
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Target Sample Size
|
Total Sample Size="82"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
this is a prospective observational study of patients with new onset partial seizures.the patients having lesion fulfilling criteria of SCG (as defined by Rajshekhar et al) in CECT Brain and patients having normal neuroimaging (both CECT as well as MRI with GAD)will be followed for seizure recurrence for atleast 6 months.the risk of seizure recurrence will be compared in both the groups and predictors of seizure recurrence will be evaluated. |