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CTRI Number  CTRI/2024/09/073349 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Modifying duration of steroid therapy in worm infestation of brain based on initial size 
Scientific Title of Study   Baseline cyst size guided increase in duration for steroid therapy in viable parenchymal neurocysticercosis a pilot prospective interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyabrata Samal 
Designation  Senior Resident Pediatric Neurology  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Pediatrics, Mother and Child block, Eighth floor, All India Institute of Medical Sciences, New Delhi New Delhi DELHI 110029 India

North East
DELHI
110029
India 
Phone  9891446467  
Fax    
Email  priyabrata2607@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Biswaroop Chakrabarty  
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Pediatrics, Mother and Child block,Eighth floor, All India Institute of Medical Sciences, New Delhi New Delhi DELHI 110029 India

North East
DELHI
110029
India 
Phone  9818260603  
Fax    
Email  biswaroopchakrabarty@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Biswaroop Chakrabarty  
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Pediatrics, Mother and Child block,Eighth floor, All India Institute of Medical Sciences, New Delhi New Delhi DELHI 110029 India

North East
DELHI
110029
India 
Phone  9818260603  
Fax    
Email  biswaroopchakrabarty@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029,India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi 
Type of Sponsor  Government medical college 
 
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 Biswaroop Chakrabarty  All India Institute of Medical Sciences, New Delhi  pediatric neurology division, department of pediatrics,8th floor,Mother and child block
North East
DELHI 		 9818260603

drbiswaroopchakrabarty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B690||Cysticercosis of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Duration of steroid therapy based on baseline cyst size (long arm)  Diagnosis will be confirmed as per standard globally accepted criteria and after applying inclusion and exclusion criteria allocation to respective groups will be made as mentioned below: Group 1 (cyst/s more than or equal to 0.7cm): Albendazole 15 mg/kg/day in two divided doses X 7 days PLUS Dexamethasone 0.6 mg/kg/day in four divided dose X 10 days (started 2 days before Albendazole) followed by 4 days tapering  
Comparator Agent  Duration of steroid therapy based on baseline cyst size(short arm)  Group 2 (cyst/s less than 0.7cm): Albendazole 15 mg/kg/day in two divided doses X 7 days PLUS Dexamethasone 0.6 mg/kg/day in four divided dose X 5 days (started 2 days before Albendazole) 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Children and adolescents aged 2-18 years
2.Parenchymal NCC, viable (vesicular/colloidal), up to 5 in number
3.In multiple lesions with sizes less than as well as more than 0.7 cm, it will be included in the 14 days steroid group and only the more than 0.7 cm cyst outcome will be analysed 
 
ExclusionCriteria 
Details  1.Received anticysticidal and steroid therapy in the last 6 months
2.Need for repeat steroid therapy within 6 months follow up
3.Raised ICP, cysticercal encephalitis
4.Extra-parenchymal NCC, intra-ocular NCC
5.Critically sick children
Co-existing known chronic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In children and adolescents aged 2-18 years with viable parenchymal NCC (up to 5 lesions), in cysts more than or equal to 0.7 cm, receiving Dexamethasone (0.6 mg/kg/day) for 14 days, to estimate the proportion of resolved cysts at 6 months (+ 1 month) on CECT Head post completion of albendazole and steroid therapy  6 months post therapy 
 
Secondary Outcome  
Outcome  TimePoints 
In children and adolescents aged 2-18 years with viable parenchymal NCC (up to 5 lesions), in cysts less than 0.7 cm receiving Dexamethasone (0.6 mg/kg/day) for 5 days, to estimate the proportion of resolved cysts at 6 months (+ 1 month) on CECT Head post completion of albendazole and steroid therapy
To estimate breakthrough seizure rates in both the groups over at least 6 months follow up post completion of albendazole and steroid therapy 		 Follow up after 6 months of therapy 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   14/09/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

        Patients will be enrolled from Pediatric OPD, Casualty or Ward based on inclusion criteria as enumerated.The baseline and 6 months CT will be interpreted at the Dept of Radiodiagnosis under the supervision of co-guide from the same. Clinically patients will be followed up at 2 and 4 weeks post initiation of treatment and then at 3 and 6 months post completion of therapy apart from whenever indicated otherwise.Telephonically they will be reviewed every week.BP and blood glucose monitoring once on 5th day of 5 days arm and 7th and 14th days of 14 days arm will be done.At least 30 cysts will be enrolled in the study as per sample size calculation and feasibility of the study in the population.Data will be entered in a pre-designed proforma and statistical analysis will be done as applicable.

 
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