Epistaxis or nose bleeding is one of the most common otorhinolaryngological emergencies. Most nosebleeds are minor and stop with nasal compression but severe bleeding needs serious management and special treatment. Chronic and recurrent epistaxis affected on quality of life and lead to anemia. .in this study we evaluate the effect of the achillia (one of the Herbal medicine) in treatment of epistaxis. The anticoagulant effect of this drug was interesting for humanity from many years ago. In attention to the effect of achillia on nasal mucosa in rabbits, it seems evaluation of effect of this drug in idiopathic and recurrent epistaxis can be a new opinion in treatment of epistaxis.
the patients who referred to the clinic of Besat hospital with recurrent epistaxis (minimum of 3 times per 2 months) and no specific etiology detect on history and physical exam will be included in this study.in intervention group: vitamin A ointment will be applied intranasal every other day with Achillia ointment for 10 days and in Control group: vitamin A ointment will be applied intranasal every other day with placebo ointment for 10 days.then on 11th day nasal exam and coagulation tests will be done and after one month and 3 months the patient will be visited and the amount of epistaxis will be recorded according to Epistaxis Severity Score (ESS) this study is randomised and blind
General information
Acronym
The Assessment of Achillea millefolium ointment therapeutic effects on idiopathic recurrent epi
IRCT registration information
IRCT registration number:IRCT201410303186N6
Registration date:2015-04-28, 1394/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-28, 1394/02/08
Registrant information
Name
Farnaz Hashemian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 9001
Email address
hashemian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Assessment of Achillea millefolium ointment therapeutic effects on idiopathic recurrent epistaxis: A Randomized double blind clinical trial study
Public title
Anti nosebleeds effect of Achillia ointment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critria: the patients who referred to the clinic of Besat hospital with recurrent epistaxis (minimum of 3 times per 2 months) and no specific etiology detect on history and physical exam
Exclusion criteria:
1- Age under 12 and above 50 years old.
2- Pregnancy.
3- OCP use.
4- Hx of ischemic heart disease.
5- Hx of hypertension.
6- Hx of thromboamboli.
7- Hx of allergy to Achillia
8- Coagulation disorder.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmide Blvd., Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
p-16-35-9-2893
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
خونریزی بینی
Primary outcomes
1
Description
Bleeding
Timepoint
Day 11th, fisrt month and third month after drug administration
Method of measurement
Epistaxis Severity score
Secondary outcomes
1
Description
Adverse effect
Timepoint
Day 11th, first month and third month after drug administration
Method of measurement
History and clinical examination
Intervention groups
1
Description
Intervention group: vitamin A ointment is applied intranasal every other day with Achillia ointment for 10 days.
Category
Treatment - Drugs
2
Description
Control group: vitamin A ointment is applied intranasal every other day with placebo ointment for 10 days.