| CTRI Number |
CTRI/2020/11/028823 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
02/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between chlorpromazine with olanzapine vs chlorpromazine alone in the treatment of hiccups in patients who had traumatic brain injury |
|
Scientific Title of Study
|
Comparative evaluation of combination therapy with chlorpromazine and olanzapine vs chlorpromazine alone for treatment of hiccups in traumatic brain injury patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meera Srinivasan |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Institute of medical sciences
Banaras hindu University
Varanasi
Institute of medical sciences
Banaras hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09884838128 |
| Fax |
|
| Email |
meera.srinivasan64@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGhanshyam yadav |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Department of anaesthesia
Trauma centre
Banaras hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meera Srinivasan |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Department of anaesthesia
Institute of medical sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09884838128 |
| Fax |
|
| Email |
meera.srinivasan64@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Trauma centre
Institute of medical sciences
Banaras Hindu University
Varanasi |
|
|
Primary Sponsor
|
| Name |
Trauma centre Banaras Hindu University |
| Address |
Department of anaesthesia
Trauma centre
Institute of medical sciences
Banaras Hindu University |
| 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 |
| Meera srinivasan |
Trauma centre, Banaras Hindu University |
Department of anaesthesia
Trauma centre
Institute of medical sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH |
9566290935
meera.srinivasan64@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparitive evaluation of combination therapy with chlorpromazine and olanzapine vs chlorpromazine alone for the treatment of hiccups in traumatic brain injury patients |
Patients with traumatic brain injury having hiccups will be divided into 2 groups of 45 each
one group will receive chlorpromazine 25 mg twice daily for 5 days and the other group will receive 25mg chlorpromazine twice daily and olanzapine 5 mg once daily for 5 days
reduction in frequency of hiccups will be monitored in both the groups |
| Comparator Agent |
Comparitive study between monotherapy with chlorpromazine vs chlorpromazine and olanzapine in the treatment of hiccups in traumatic brain injury patients |
Patients with traumatic brain injury having hiccups will be divided into 2 groups of 45 each
one group will receive tablet chlorpromazine 25 mg twice daily( orally or through rules tube) for 5 days and the other group will receive 25mg chlorpromazine twice daily and olanzapine 5 mg once daily for 5 days
reduction in frequency of hiccups will be monitored in both the groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having intracranial injury confirmed by ct scan |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Patients with diabetes/copd/hypertension
Patient with end organ damage
Refusal to participate |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in frequency of hiccups with combination vs monotherapy |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Easy weaning from ventilator due to the remission of hiccups |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/11/2020 |
| 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="2"
Days="10" |
|
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 - NO
|
|
Brief Summary
|
This is a prospective comparitive study between combination therapy vs mono therapy in the treatment of hiccups on traumatic brain injury patients |