Bell´s palsy is a condition characterized by an acute onset of facial nerve palsy. Treatment of Bell palsy varies, and no clear consensus exists. Most physicians prescribe corticosteroids as a primary treatment. However, due to possible conflicts with the treatment of HSV and other viral infections virus also seems logical. There is insufficient evidence to support the use of anti-virus and it is contraversion. Based on the serological evidence obtained, some experts treated patients with Anti-virus, including acyclovir, valacyclovir Famcyclovir. Our goal is to enable patients to benefit from this treatment. This study is a clinical trial. The severity of the disease and improve the treatment of Bell´s palsy is measured according to Table House Bruckman. A sample of 100 patients admitted to the pediatric clinic based and randomly divided into two groups. A: Combination therapy with prednisone and acyclovir B: Treatment with prednisolone alone
Inclusion Criteria:
1. aged 2 to 18 years
2. Patients who have just seventh nerve palsy.
3. No more than three days after the symptoms have passed.
After investigating the specific cause is not found for seven nerve palsy.
Exclusion Criteria:
1. Patients with paralysis of the seventh nerve palsy, other cranial nerves are.
2. Be over the last three days of onset of symptoms.
3. After examining the specific cause is found for paralysis.
4. The last two weeks of treatment is anti-herpetic received.
5. Be sensitive to acyclovir
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062210087N1
Registration date:2013-11-10, 1392/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-10, 1392/08/19
Registrant information
Name
Ali Khajeh
Name of organization / entity
Zahedan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+54 13220316
Email address
khajeha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Deputy of Research and Technology
Expected recruitment start date
2011-09-20, 1390/06/29
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of combination therapy of Prednisolone and Acyclovir with Prednisolone alone in Bell´s palsy patients aged 2-18 years
Public title
Efficacy of corticosteroid and acyclovir in Bell´s palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. aged 2 to 18 years
2. Patients who have just seventh nerve palsy.
3. No more than three days after the symptoms have passed.
After investigating the specific cause is not found for seven nerve palsy.
Exclusion Criteria:
1. Patients with paralysis of the seventh nerve palsy, other cranial nerves are.
2. Be over the last three days of onset of symptoms.
3. After examining the specific cause is found for paralysis.
4. The last two weeks of treatment is anti-herpetic received.
5. Be sensitive to acyclovir
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Daneshgah street, Dr Hesabi square,zahedan university of medical sciences, campus
City
Zahedan
Postal code
Approval date
2011-12-02, 1390/09/11
Ethics committee reference number
90-2049
Health conditions studied
1
Description of health condition studied
bell palsy
ICD-10 code
G51.0
ICD-10 code description
Bell palsy
Primary outcomes
1
Description
severity of palsy according to house_brackmann scale
Timepoint
1 and 2 month after treatment
Method of measurement
house_brackmann scale
Secondary outcomes
empty
Intervention groups
1
Description
The first group Prednisolone 2 mg per kg of body weight to be given seven days
Category
Treatment - Drugs
2
Description
The second group of Prednisolone at a dose of 2 mg per kg of body weight, Acyclovir tablets of 20 mg per kg of body weight should be given for seven days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Ali khajeh
Street address
Ali Asghar Hospital, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza mahmoodzade sagheb
Street address
Zahedan University of Medical Sciences
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Sara Sheikhvesi
Position
stager
Other areas of specialty/work
Street address
Emam Ali Hospital
City
Zahedan
Postal code
Phone
+98 54 1242 1638
Fax
Email
s_sheikhveisi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science , Zahedan , Iran
Full name of responsible person
Ali Khajeh
Position
Pediatric neurologist
Other areas of specialty/work
Street address
Ali Asghar Hospital
City
Zahedan
Postal code
Phone
+98 54 1322 0316
Fax
Email
drkhajehneuro@gmail
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Scince
Full name of responsible person
Sara Sheikhveisi
Position
stager
Other areas of specialty/work
Street address
Emam Ali Hospital
City
Zahedan
Postal code
Phone
+98 54 1242 1638
Fax
Email
s_sheikhveisi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)