Determining the effectiveness of timolol nasal spray in frequent epistaxis patients
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3 on 35 patients in each group, making a total of 70 patients. Random assignment by card was used for randomization.
Settings and conduct
This study will be conducted in 2024 and 2025 at Al-Zahra Hospital in Isfahan under the supervision of Isfahan University of Medical Sciences. People participating in this study will be divided into 2 groups. In this study, the patient and the statistician are not aware of the grouping of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of recurrent epistaxis with at least 4 episodes in the last four weeks and at least one episode in the last week;
Exclusion criteria:
Pregnancy and breastfeeding; asthma or chronic lung disease; coagulation problems like hemophilia; hypotension; heart failure; bradycardia; pheochromocytoma or severe peripheral circulatory disorders; Receiving calcium antagonists or antiarrhythmics or clonidine, lidocaine; beta blockers fluctafenine, sultopride or amiodarone; anticoagulants; timolol sensitivity; Nose surgery in the last month
Intervention groups
People participating in this study will be divided into 2 groups. The first group as an intervention group will be treated with half percent timolol nasal spray made by Raha Pharmaceutical Company and the second group will be treated with placebo made by the Faculty of Pharmacy. The method of treatment in both groups will be similar and 2 times a day for 4 weeks.
Main outcome variables
Epistaxis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240327061371N1
Registration date:2025-03-02, 1403/12/12
Registration timing:registered_while_recruiting
Last update:2025-03-02, 1403/12/12
Update count:0
Registration date
2025-03-02, 1403/12/12
Registrant information
Name
Afrooz Eshaghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 0092
Email address
afroozeshaghian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-31, 1403/08/10
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical timolol on recurrent epistaxis: a clinical trial
Public title
Effect of topical timolol on recurrent epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of recurrent epistaxis with at least 4 episodes in the last four weeks
Exclusion criteria:
Pregnancy
Having bronchial asthma or chronic lung disease
Suffering from diseases that cause coagulation problems, such as hemophilia
Patients with low blood pressure
Having pheochromocytoma or severe peripheral blood circulation disorders
Receiving calcium antagonists
History of nose surgery in the last month
breastfeeding
Having chronic lung disease
Patients with heart failure
Patients with bradycardia
Patients with other cardiac contraindications for beta-blockers
Patients with peripheral vascular circulation dysfunction
Receiving amiodarone
Receiving antiarrhythmics
Receiving clonidine
Receiving lidocaine
Receiving beta blockers
Receiving fluctafenine
Receiving soltopride
Hypersensitivity to timolol
Use of anticoagulants
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random: Random allocation rule will be used for random sampling. In this way, 35 cards of the same shape with the name of group A and 35 cards of the same shape with the name of group B are thrown into a container. Then the cards are randomly removed from the container without replacement and the created sequence is recorded, and sampling is also done from Between eligible patients will be based on this sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blinding: The placebo will be in the form of normal saline by the pharmacist's colleague in the same containers as the drug spray , which will be poured into the containers and opened after the completion of the coding study. patient and statistician are blinded.
In this way, eligible patients referring to otolaryngology outpatient clinics will be assigned to group A or B based on the rule of random assignment. The attending physician is aware of the grouping (A = timolol spray B = placebo spray), the patient will be informed about the procedure based on the explanation of the intervention method and obtaining informed consent, but he does not know the allocation to the study group. The groups will not be notified and it only knows A and B groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine - Isfahan University of Medical Sciences
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-10-12, 1403/07/21
Ethics committee reference number
IR.MUI.MED.REC.1403.260
Health conditions studied
1
Description of health condition studied
epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Epistaxis
Timepoint
Before the intervention and 2 weeks, 4 weeks, and 8 weeks after the intervention
Method of measurement
History taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: half percent timolol nasal spray manufactured by Raha Pharmaceutical Company, one puff in each nostril twice a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Normal saline nasal spray made by Faculty of Pharmacy, one puff in each nostril twice a day for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Atefeh Sharifi
Street address
Alzahra hospital, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
75731-81746
Phone
+98 31 3822 0000
Email
sharifiatefeh7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Esfahan University of Medical Sciences, Hezarjarib Street
City
اصفهان
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Afrooz Eshaghian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani Hospital, Kashani St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۳۹۸۳۴۳۴
Phone
+98 31 3233 0091
Email
afroozeshaghian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afrooz Eshaghian
Position
assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani Hospital, Kashani St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۳۹۸۳۴۳۴
Phone
+98 31 3233 0091
Email
afroozeshaghian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afrooz Eshaghian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani Hospital, Kashani St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۳۹۸۳۴۳۴
Phone
+98 31 3233 0091
Email
afroozeshaghian@gmai.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD