UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052217 |
|---|---|
| Receipt number | R000059598 |
| Scientific Title | Efficacy of 0.1% Xylometazoline-Hydrochloride nasal decongestant spray in Post-operative sign/symptom relief following Septoplasty: A Prospective-experimental Study. |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2023/10/08 13:39:31 |
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Basic information
Public title
Efficacy of 0.1% Xylometazoline-Hydrochloride nasal decongestant spray in Post-operative sign/symptom relief following Septoplasty: A Prospective-experimental Study.
Acronym
Efficacy of 0.1% Xylometazoline-Hydrochloride Nasal Decongestant Spray in Post-septoplasty Sign/Symptom Relief (ENSPS-EPES).
Scientific Title
Efficacy of 0.1% Xylometazoline-Hydrochloride nasal decongestant spray in Post-operative sign/symptom relief following Septoplasty: A Prospective-experimental Study.
Scientific Title:Acronym
Efficacy of 0.1% Xylometazoline-Hydrochloride Nasal Decongestant Spray in Post-septoplasty Sign/Symptom Relief (ENSPS-EPES).
Region
| Asia(except Japan) |
Condition
Condition
post-operative relief from signs and symptoms following Septoplasty.
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy of 0.1% Xylometazoline-Hydrochloride nasal decongestant spray in post-septoplasty sign/symptom relief in comparison with physiologic 0.9% isotonic saline nasal spray as a therapeutic adjunct.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Post-operative septoplasty sign/symptom relief using the assigned drug.
Key secondary outcomes
Patient Satisfaction with the assigned drug.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.9% Normal Saline Nasal Spray (Placebo)
Interventions/Control_2
0.1% Xylometazoline Hydrochloride Nasal Spray
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 15-60 years undergoing septoplasty for symptomatic deviated nasal septum (DNS) belonging to UH and CGH were included in the study.
Key exclusion criteria
Patients not from UH and CGH of age <15 years and >60 years, admitted for revision surgery or trauma or in which septoplasty was performed along with other nasal procedures like turbinate reduction or functional endoscopic sinus surgery or submucosal resection (SMR), history of acute or chronic rhinosinusitis and obstructive sleep apnoea, perforated nasal septum, insufficient nasal valve, granulomatous condition of the nose and sinuses, pregnancy, craniofacial malformation (cleft palate or cleft lip), HIV or any bleeding diathesis condition, malignancy, allergic rhinitis, usage of antihistamines or anticoagulants, and history of allergies to allocated drugs were excluded from the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Dr. Shanila |
| Middle name | |
| Last name | Feroz |
Organization
United Medical and Dental College
Division name
Department of ENT
Zip code
75190
Address
R47J+R2W, UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh, Pakistan
TEL
+923332102221
shanilaali@hotmail.com
Public contact
Name of contact person
| 1st name | Muhammad Hamza |
| Middle name | |
| Last name | Dawood |
Organization
United Medical and Dental College
Division name
MBBS
Zip code
75190
Address
R47J+R2W, UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sind
TEL
+923303051270
Homepage URL
Muhammadhamzadawood86@gmail.com
Sponsor or person
Institute
None.
Institute
Department
Personal name
None.
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Pakistani.
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
United Medical and Dental College
Address
R47J+R2W, UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh, Pakistan
Tel
+923002510190
azenmu@yahoo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
UTN NO.: U1111-1297-8305
Org. issuing International ID_1
WHO
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
United Medical and Dental College(Pakistan), United Hospital(Pakistan), Creek General Hospital (Pakistan).
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/19CRbP2jsUrW2AgfouUAxoEBfUOdRlwDc/edit
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
106
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 02 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 03 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059598
