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CTRI Number  CTRI/2022/10/046712 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 13/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   A study on incidence of stroke 
Scientific Title of Study   A study on etiology ,clinical features and outcome of cerebral venous sinus thrombosis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Panchami Pradeep Kumar 
Designation  Resident  
Affiliation  SCHOOL OF MEDICINE , Dr. DY Patil Hospital  
Address  Department of Medicine , school of medicine , Dr.D Y Patil Hospital and deemed to be University Nerul, NAVI Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9619293896  
Fax    
Email  panchami95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Panchami Pradeep Kumar 
Designation  Resident  
Affiliation  SCHOOL OF MEDICINE , Dr. DY Patil Hospital  
Address  Department of Medicine , school of medicine , Dr.D Y Patil Hospital and deemed to be University Nerul, NAVI Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9619293896  
Fax    
Email  panchami95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nivedita Moulick  
Designation  Professor 
Affiliation  Dr DY Patil School of Medicine  
Address  Department of Medicine , school of medicine , Dr.D Y Patil Hospital and deemed to be University Nerul, NAVI Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9833022282  
Fax    
Email  ndmoulick@rediffmail.com  
 
Source of Monetary or Material Support  
School of medicine D Y Patil deemed to be university  
 
Primary Sponsor  
Name  Dr Panchami Pradeep Kumar  
Address  department of medicine , school of medicine ,Dr DY Patil hospital and deemed to be university , sector 5,Nerul , navi mumbai  
Type of Sponsor  Other [Self ] 
 
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 Panchami Pradeep Kumar  Dr. D .Y Patil Hospital  department of medicine , school of medicine ,Dr DY Patil hospital and deemed to be university , sector 5 nerul , navi mumbai
Thane
MAHARASHTRA 		 9619293896

panchami95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I676||Nonpyogenic thrombosis of intracranial venous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Radiologically diagnosed case of cerebral venous sinus thrombosis  
 
ExclusionCriteria 
Details  Previously diagnosed case of cerebral venous sinus thrombosis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study on etiology , clinical features and outcome of cerebral venous sinus thrombosis over a period of 12 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/11/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [panchami95@gmail.com].

  6. For how long will this data be available start date provided 16-01-2023 and end date provided 01-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The present study is the clinical observation study for completion under Dr DY Patil hospital deemed to be university 
Total duration is 1 year 
TITLE -  A study on etiology, clinical features and outcome of cerebral venous sinus thrombosis 
Study group - sample size 40
Study center - school of medicine Dr DY Patil deemed to be university and hospital , Nerul , Navi Mumbai 
PG Scholar - Dr Panchami Pradeep Kumar 
Guide - Dr Nivedita Moulick 
 
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