CTRI/2024/08/072164Not yet recruitingPhase 1
To study the effects of HBOT in patients with Bells Palsy
RENNY JUSTINE1 site in 1 country46 target enrollmentStarted: August 25, 2024Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- To study the symptomatic improvement of lagophthalmos in patients of Bell’s Palsy undergoing HBOT
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with a House Brackman Grade of 3 and above will only be considered for HBOT.
Exclusion Criteria
- •Patients must not have any active lung disease or any other contraindication for HBOT.
Outcomes
Primary Outcomes
To study the symptomatic improvement of lagophthalmos in patients of Bell’s Palsy undergoing HBOT
Time Frame: 10 days, 20 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Renny Justine
INHS Asvini
Study Sites (1)
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