| CTRI Number |
CTRI/2024/08/072164 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of HBOT in patients with Bells Palsy |
|
Scientific Title of Study
|
To study the effects of HBOT in patients with Bells Palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renny Justine |
| Designation |
Post Graduate Resident |
| Affiliation |
INHS Asvini |
| Address |
Recompression Chamber Complex
Department of Marine Medicine
Institute of Naval Medicine
INHS Asvini
Colaba
Mumbai
400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9747276964 |
| Fax |
|
| Email |
rennyjustine3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C S Mohanty |
| Designation |
Associate Professor |
| Affiliation |
INHS Asvini |
| Address |
recompression Chamber Complex
Department of Marine Medicine
Institute of Naval Medicine
Department of Marine and Hyperbaric Medicine
INHS Asvini
Colaba
Mumbai
400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
400005 |
| Fax |
|
| Email |
drmohantycs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C S Mohanty |
| Designation |
Associate Professor |
| Affiliation |
INHS Asvini |
| Address |
Recompression Chamber Compex
Department of Marine Medicine
Institute of Naval Medicine
Department of Marine and Hyperbaric Medicine
INHS Asvini
Colaba
Mumbai
400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
400005 |
| Fax |
|
| Email |
drmohantycs@gmail.com |
|
|
Source of Monetary or Material Support
|
| INHS Asvini
Colaba
Mumbai
Maharashtra
400005
India
|
|
|
Primary Sponsor
|
| Name |
RENNY JUSTINE |
| Address |
Institute of Naval Medicine
INHS Asvini
Colaba
Mumbai
400005 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Renny Justine |
Indian Naval Hospital Ship Asvini Hospital |
Recompression Chamber Complex
Department of Marine Medicine
Institute of Naval Medicine
Department of Marine and Hyperbaric Medicine
INHS Asvini
Colaba
Mumbai
400005
Mumbai
MAHARASHTRA |
9747276964
rennyjustine3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G510||Bells palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical Oxygen |
Medical Oxygen given at fixed intervals in hyperbaric chamber as already being done in Hyperbaric Oxygen Treatment. |
| Comparator Agent |
Normal Air |
Patients who are not taking Medical Oxygen under high pressure. These patients will not be given HBOT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a House Brackman Grade of 3 and above will only be considered for HBOT.
|
|
| ExclusionCriteria |
| Details |
Patients must not have any active lung disease or any other contraindication for HBOT.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the symptomatic improvement of lagophthalmos in patients of Bell’s Palsy undergoing HBOT |
10 days, 20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 1 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
TITLE - To study the effect of Hyperbaric Oxygen Therapy in patients wit Bells Palsy.AIM AND OBJECTIVE - To study the symptomatic improvement of lagophthalmos in patients with Bells Palsy.
46 patients will be selected for the study at which they will be grouped into one which receive Hyperbaric Oxygen and one group which do not get Hyperbaric Oxygen Therapy. We will see how much improvement is there in the group which gets the HBOT. |