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Comparison of the effect of mellissan Gel with Acyclovir cream for the treatment of recurrent herpes labialis

Protocol summary

Summary
The aim of this randomized double blind clinical trial was to compare the treatment efficacy of Melissan gel with cream of Acyclovir in the treatment of recurrent herpes labialis. In this study, 60 patients with history of recurrent herpes labialis among students and employers of Yazd dental school and residents of dormitory were randomly allocated into intervention or control group to receive melissan gel or Acyclovir cream, respectively. Intensity of pain, size of the lesion, inflammation, and healing were measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138708191442N1
Registration date: 2011-09-24, 1390/07/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-24, 1390/07/02
Registrant information
Name
Hakimeh Ahadian
Name of organization / entity
Faculty of Dentistry, Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1625 5881
Email address
dr_ahadian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2009-04-05, 1388/01/16
Expected recruitment end date
2010-03-16, 1388/12/25
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of the effect of mellissan Gel with Acyclovir cream for the treatment of recurrent herpes labialis
Public title
Gel of mellissan in the treatment of the cold sore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: students of Yazd dental faculty with history of recurrent herpes labialis & individuals in Yazd medicine University dormitory with history of RHL Exclusion criteria: history of allergy, RAUs, any systemic disease & drug consumption
Age
No age limit
Gender
Female
Phase
N/A
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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences
Street address
Dahe Fajr Blvd., Yazd
City
Yazd
Postal code
Approval date
2009-04-11, 1388/01/22
Ethics committee reference number
4556/1/17/پ

Health conditions studied

1

Description of health condition studied
Recurrent herpes labialis
ICD-10 code
B00.1
ICD-10 code description
Herpesviral vesicular dermatitis, Herpes simplex facialis, labialis

Primary outcomes

1

Description
Size of ulcer
Timepoint
1, 2, 4, 7 days
Method of measurement
extensions of ulcer in milimeter quare

Secondary outcomes

1

Description
The severity of pain
Timepoint
1, 2, 4, 7 days
Method of measurement
VAS

2

Description
Erythema arround the lesion
Timepoint
1, 2, 4, 7 days
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: Melissan gel, three times a day, for a week
Category
Treatment - Drugs

2

Description
Control group: Acyclovir cream, three times a day, for a week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Dormity, Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hakimeh Ahadian
Street address
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ezoddini Ardakani
Street address
Research Department, Building No 2, Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi 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
Dental Faculty, Yazd
Full name of responsible person
Dr Hakimeh Ahadian
Position
Assistant professor, Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences
Other areas of specialty/work
Street address
Dental Faculty, Daheye Fajr Blvd., North Emam street, Yazd
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
+98 53 1625 0344
Email
dr_ahadian@yahoo.comdrahadian@ssu.ac.irdrkarbassi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Denta Faculty of Yazd
Full name of responsible person
Dr Hakimeh Ahadian
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental Faculty, Daheye Fajr Blvd., North Emam street, Yazd
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
drahadian@ssu.ac.irdr_ahadian@yahoo.com-
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental Faculty, Yazd
Full name of responsible person
Dr Hakimeh Ahadian
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental Faculty, Daheye Fajr Blvd., North Emam street, Yazd
City
Yazd
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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