Idiopathic facial nerve paralysis is the most common cause of acquired, acute and non-traumatic facial nerve paralysis which is usually unilateral.Objectives: This study investigated the effect of single acyclovir or prednisolone and their combination therapy in the treatment of facial nerve palsy. Design:To do this, a randomized, study was designed without the use of placebos. Participants including
major eligibility criteria:Therefore all patients over ten years of age with unilateral facial nerve palsy were entered into the study and all patients who were found to have a cause for their palsy or more than 7 days had passed from the onset of their palsy were excluded from the study. The sample size was equal to 180. All Setting and conduct: patients were graded according to House-Brackman criteria and then randomly divided into three groups. Intervention:The first group received 1 mg/kg prednisolone for 15 days and then the drug was gradually tapered, the second group received 400 mg oral acyclovir every 5 hours per day for 10 days, and the third group received a combination of these two drugs. Then the patients were followed up every 15 days for 3 months and the facial nerve function was assessed using House-Brackmann score.Main outcome measures: Changes in House-Brackman grades is our primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109187575N1
Registration date:2011-11-20, 1390/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-20, 1390/08/29
Registrant information
Name
Alireza Rezaei Ashtiani
Name of organization / entity
Arak University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 7828
Email address
dr.ashtiani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences,Vice chancellor for research
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of prednisolone, acyclovir, and combination of these drugs in Bell´s Palsy
Public title
Comparison of therapeutic effects of prednisolone, acyclovir, and combination of these drugs in Bell´s Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Patients with Bell´s palsy; Age over 10 years
Exclusion Criteria:
More than 7 days have passed since the onset of paralysis; Finding another cause for the paralysis
Age
From 10 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Ethical committee of Arak University Of Medical Science
Street address
Alamalhoda ave, Parastar Square,Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2010-04-27, 1389/02/07
Ethics committee reference number
89-77-3
Health conditions studied
1
Description of health condition studied
Bell's palsy
ICD-10 code
G51.0
ICD-10 code description
Facial palsy
Primary outcomes
1
Description
House-Brackmann score
Timepoint
Each 15 days
Method of measurement
Calculate House-Brackmann score
Secondary outcomes
1
Description
Failure to treatment
Timepoint
The end of month 3
Method of measurement
No reduce of House-Brackmann score
Intervention groups
1
Description
prednisone, a dose of 1 mg/kg body weight was given daily for 3 days. The treatment was tapered over the next 12 days
Category
Treatment - Drugs
2
Description
Acyclovir, 400 mg every 5 hours per day for 10 days
Category
Treatment - Drugs
3
Description
Prednisone, a dose of 1 mg/kg body weight was given daily for 3 days. The treatment was tapered over the next 12 days. Those taking acyclovir received 400 mg every 5 hours per day for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie-Asr Hospital
Full name of responsible person
Dr Alireza Rezaei Ashtiani
Street address
Valie-Asr Hospital , Pirozi Ave, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Dr Saied Changizi Ashtiani
Street address
Arak University of Medical Sciences , Basij square,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Rezaei Ashtiani
Position
Neurologist,Assistant professor
Other areas of specialty/work
Street address
Department of Internal Medicine,Valie-Asr Hospital,Pirozi Ave.Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
dr.ashtiani@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Rezaei Ashtiani
Position
Neurologist,Assistant professor
Other areas of specialty/work
Street address
Department of Internal Medicine,Valie-Asr Hospital,Pirozi Ave.Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
dr.ashtiani@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Rezaei Ashtiani
Position
Neurologist,Assistant professor
Other areas of specialty/work
Street address
Department of Internal Medicine,Valie-Asr Hospital,Pirozi Ave.Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
dr.ashtiani@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)