| CTRI Number |
CTRI/2021/12/039005 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
treatment of seizure |
|
Scientific Title of Study
|
Comparison of efficacy of add on oral serratiopepitadase for reducing severity of headache during the acute phase of perilesional edema in calcified neurocysticercosis: an open labeled randomized controlled trial |
| Trial Acronym |
SPIHNC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prateek Kumar Panda |
| Designation |
Assistant professor |
| Affiliation |
Department of Pediatrics, AIIMS, Rishikesh |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prateek Kumar Panda |
| Designation |
Assistant professor |
| Affiliation |
Department of Pediatrics, AIIMS, Rishikesh |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prateek Kumar Panda |
| Designation |
Assistant professor |
| Affiliation |
Department of Pediatrics, AIIMS, Rishikesh |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Virabhadra Road, Rishikesh, 249203, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Rishikesh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRATEEK KUMAR PANDA |
AIIMS, Rishikesh |
Dept of pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G060||Intracranial abscess and granuloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paracetamol alone |
oral paracetamol 15 mg/kg as and when required (maximum 4 times a day) for seven days |
| Intervention |
Serratiopeptidase |
oral serratiopeptidase 5 mg BD for 7 days with oral paracetamol 15 mg/kg as an d when required |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Calcified NCC
Perilesional edema on CT or MRI brain
Headache for at least 48 hours, not attributable to any other etiology
|
|
| ExclusionCriteria |
| Details |
Viable Neurocysticercosis
Absence of perilesional oedema on neuroimaging
Any coexisting primary or secondary headache etiology
Previously documented allergy to serratiopeptidase
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HIT score in both arms |
At baseline and at 1 week follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in HIT score in both arms on day 14 on follow up as compared to baseline |
Reduction in HIT score in both arms on day 14 on follow up as compared to baseline |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
31/12/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial will explore the efficacy of add on oral serratiopeptidase 5 mg BD for seven days in reducing the severity of headache in children with calcified neurocysticercosis aged 5-18 years with perilesional oedema in acute stage, when measured on day 7 by Headache impact test-6 score |