| CTRI Number |
CTRI/2025/02/081343 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study evaluating the efficacy of corticosteroids versus placebo in improving neurological outcomes in hanging patients |
|
Scientific Title of Study
|
Efficacy of corticosteroid therapy on neurological outcomes in near-hanging patients with altered sensorium: A multi-centre, double-blinded, placebo-controlled, randomized trial |
| Trial Acronym |
CHANGING |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramadoss R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Medicine
JIPMER
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910952320 |
| Fax |
|
| Email |
ramadoss2912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramadoss R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Medicine
JIPMER
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910952320 |
| Fax |
|
| Email |
ramadoss2912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramadoss R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Medicine
JIPMER
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910952320 |
| Fax |
|
| Email |
ramadoss2912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Dhanvantari Nagar
Puducherry-605006 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswin K |
Indira Gandhi Medical College & Research Institute |
Vazhudavur Road, Kathirkamam, Puducherry- 605 009.
Pondicherry
PONDICHERRY |
9443345011
aswink02@gmail.com |
| Dr Ramadoss R |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Dhanvantari Nagar
Puducherry
Pondicherry
PONDICHERRY |
9910952320
ramadoss2912@gmail.com |
| Dr Ashish Behera |
Post Graduate Institute of Medical Education and Research |
Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH |
9990779286
drashishbehera@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IGMCRI- Institutional Ethics COmmittee |
Approved |
| JIPMER- Institutional Ethics Committee |
Approved |
| PGIMER- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T711||Asphyxiation due to mechanical threat to breathing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone 8 mg IV administered slow IV push stat followed by 4mg 6th hourly on Day 1.
Dexamethasone 4mg 6th hourly on Day 2 to 3.
Assessment on day 4 to see if
steroids need to be continued.
If needed further, Dexamethasone 4mg 6th hourly will be given on Day 4 to 5. |
| Comparator Agent |
Placebo |
Identically looking normal saline as long as intervention is given. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Near-hanging adult patients aged 18 years or more
Presented with altered sensorium, having a GCS score of 13 or less
Presented within 48 hours of the hanging attempt |
|
| ExclusionCriteria |
| Details |
Patients tried other methods of suicide concurrently
Treatment for more than 24 hours with 20 mg of dexamethasone or an equivalent dose of corticosteroids before enrolment.
Active tuberculosis, HIV infection, recent steroid use or other immunosuppressant therapy
Definite indication or contra-indication to steroid therapy
Allergies to the study drug
Pregnancy or breastfeeding
Patients having underlying neurological diseases
Hanging induced cervical spine injury
Moribund patients
Informed consent not given |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to assess the neurological outcome in near hanging patients with altered sensorium after treating them with corticosteroid or placebo.
The Glasgow outcome scale is used to assess neurological outcomes whether it is good or poor.
Good outcomes include Complete recovery and Disabled but independent
Poor outcomes include Death, Persistent vegetative state and Dependent on daily life activities |
day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The neurological outcome using Glasgow outcome scale |
at the time of discharge |
| length of hospital stay |
at the time of discharge |
| in-hospital complications |
during hospitalization |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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)
|
Hanging is the most common method of suicide in India, accounting for 58.2% of all suicides. In hanging attempt, Due to the pressure on the major vessels and airway, hypoxic-ischemic damage and cerebral edema occur in the brain. Corticosteroids are widely used to reduce cerebral edema. However, evidence for the utility of steroids for this indication is lagging, and it is not proven in randomized controlled trials.
Near hanging patients with altered sensorium (Glasgow Coma Scale of 13 or less) will be recruited in this study. In addition to standard medical care, participants will undergo randomization to receive either steroid therapy or a placebo for cerebral edema. The neurological status at the time of discharge and day 28 will be assessed using the Glasgow Outcome Scale, whether good or poor. We will also compare the length of hospital stay between the two groups and document any in-hospital complications. |