Determination of the prophylactic effect of Tranexamic acid capsule in controlling nasal hemorrhage in patients with epistaxis
Design
Non-randomized clinical trial with parallel groups, with control group, Double blind, sample size 100
Settings and conduct
All patients with epistaxis who were referred to Zahedan Khatam Hospital clinic were included by convenience sampling method. Both analgesics were in boxes A and B, and only the physician responsible for conducting the program (supervisor) was aware of the drug content of each group. In the control group, drops of NaCl (3 times a day, 5 drops per week for one week) and ointment of vitamin A (three times daily for one week) were administered and in the intervention group, drops of NaCl (3 times A daily dose of 5 drops per week for one week) and vitamin A ointment (twice daily for one week) with Tranexamic acid 500 mg every 8 hours for one week.
Participants/Inclusion and exclusion criteria
The subjects who participated in the study were referred to the Clinic of Khatam Hospital in Zahedan from all individuals with epistaxis with an idiopathic cause.
Intervention groups
Control: Chloride and ointment drops of vitamin A were prescribed
The intervention group received drops of sodium chloride and vitamin A ointment with tranexamic acid
Main outcome variables
Rebleeding within a month after the intervention;
Nausea;
Vomiting;
Satisfaction;
Sinus and nose symptoms;
Diarrhea;
Abdominal pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N7
Registration date:2019-07-10, 1398/04/19
Registration timing:retrospective
Last update:2019-07-10, 1398/04/19
Update count:0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-04-21, 1398/02/01
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Evaluation of prophylactic effect of tranexamic acid capsule on nasal hemorrhage in patients with epistaxis
Public title
Prophylactic effect of tranexamic acid capsule in controlling epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Insensitivity to the drugs used in the study
Satisfaction to enter the study
Exclusion criteria:
Patients with seizure, arterial or venous thrombosis, leukemia, lymphoma, polycythemia vera, pregnant women
Patients who have taken anticoagulants, anti-platelets and even aspirin
Age
From 15 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients were treated using pharmacologic packages prespecified by the study supervisor (supervisor). The information gathering, patient assessment, and completion forms were carried out by the program implementer and assistant who were not aware of the contents of the packages; at the analysis stage Data were also analyzed by the design and implementation consultant's consultant who was not aware of the contents of the drug packs and only the group of patients (group 1 or 2) was identified for data analysis; therefore, the study was a three-blind study, and from the patient's entry phase in the study Until the study, data collection and analysis of data, the contents of the two drug groups were unclear.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.ZAUMS.REC.1397.494
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Patient satisfaction from treatment based on questionnaire
Timepoint
Every week from the start of treatment and up to one month after treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 50 patients, drops of NaCl and vitamin A ointment with 500 mg tranexamic acid were administered every 8 hours a week.
Category
Treatment - Drugs
2
Description
Control group: For 50 patients, drops of NaCl and vitamin A ointment every 8 hours for a week were prescribed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Hospital
Full name of responsible person
Dr. Gholamali Dashti Khudaki
Street address
Salamat Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
it@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti Khudaki
Street address
Dr.Hesabi square , Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti Khudaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr. Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti Khudaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr. Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti Khudaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr.Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.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