Evaluation of the effect of lemon juice in control of spontaneous nasal bleeding
Design
A parallel randomized double-blind controlled clinical trial, will be performed on patients referred to the emergency ward with a diagnosis of spontaneous nasal bleeding. 150 patients will be randomly assigned to receive the intervention and the placebo using a random number table .
Settings and conduct
150 patients with spontaneous nasal bleeding referring to emergency ward of Rahnemoun Hospital, Yazd, after receiving an informed consent, will be assigned randomly to the A and B groups. The bottles of cottons containing lemon juice (5 drops) (intervention) or phenylephrine (placebo) will be separated by A and B labels by someone irrelevant to the study (participants and researchers will be blinded to the type of treatment). After putting lemon juice or placebo cottons in the patient's nose, nasal bleeding will be checked after 5 and 10 minutes. Patients will be followed for the next 24 hours for control of bleeding. In case of non-recovery within 10 minutes of either A or B intervention, standard therapy (anterior tampon) will be applied. The results of 2 groups will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women referred to the emergency ward of Shahid Rahnemoun Hospital, Yazd with a diagnosis of spontaneous nasal bleeding,age range of 18-55 years who wish to participate in the study. Exclusion criteria: Pregnancy and underlying liver, kidney and heart disease, hereditary or acquired coagulopathy and a history of lemon or phenylphrine or lidocaine sensitivity and trauma.
Intervention groups
Intervention: Putting cotton containing 2%lidocaine and lemon juice (5 drops) in the patient's nose
Control: Putting cotton containing 2%lidocaine and phenylephrine in the patient's nose
Main outcome variables
Nasal bleeding after 5, 10 minutes and 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180624040228N3
Registration date:2020-04-04, 1399/01/16
Registration timing:prospective
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Fahime Zeinali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9143
Email address
fghzeinaly@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation of the topical impact of lemon juice on impulse control of spontaneous nasal bleeding in patients referred to the Emergency Services
Public title
Topical impact of lemon juice on impulse control of spontaneous nasal bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women referred to the emergency department of Shahid Sadoughi and Shahid Rahnemoon Hospitals of Yazd with a diagnosis of spontaneous nasal bleeding
The age range of 18-55 years
Who wish to participate in the study
Exclusion criteria:
Pregnancy
Uunderlying liver, kidney and heart disease
Hereditary or acquired coagulopathy
History of lemon or phenylphrine or lidocaine sensitivity
Trauma
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
1.Randomization method: Simple 2.Randomization unit: Personal 3.Randomization device: Random number table .To assign individuals to the intervention and control groups, a random number table will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Cottons containing lemon juice and placebo are similar in shape and appearance, and the bottles of cottons are the same (in terms of color and shape). A and B labels will be fixed on the bottles of Cottons by someone irrelevant to the entire study. participants and researchers will be blinded to the contents in the bottles through out the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1234567890
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.100
Health conditions studied
1
Description of health condition studied
Spontaneous nasal bleeding
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Nasal bleeding
Timepoint
5 and 10 minuets and 24 hours after intervention
Method of measurement
Physical examination by the physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Put cotton containing 2% lidocaine and lemon juice (5 drops) in the patient's nose
Category
Treatment - Drugs
2
Description
Control group: Put cotton containing 2% phenylephrine and lidocaine in the patient's nose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Shahid Rahnemoun Hospital
Full name of responsible person
Behzad Zeinaly
Street address
Shahid Rahnemoun Hospital, Farokhi street
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3626 0001
Email
Rahnemoonhospital@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Emergency Shahid Sadoughi
Full name of responsible person
Behzad Zeinaly
Street address
Shahid Sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3822 9009
Email
yazd_cdc@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Mojalal
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
Fmodjallal@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behzad Zeinaly
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Ghandi Blvd., Ibn Sina Street, Shahid Sadoughi Hospital
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3822 9009
Email
fghzeinaly@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Mojalal
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Ghandi Blvd., Ibn Sina Street, Shahid Sadoughi Hospital
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3822 9009
Email
Fmodjallal@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behzad Zeinaly
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3822 9009
Email
fghzeinaly@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available