In this randomized, double blind clinical trial, the effect of topical olive leaf extract 2% on the facial herpes simplex was compared to topical Acyclovir 5% (ParsDaro) in 62 patients in 2 groups. A tine layer of each ointment was administered 5 times a day for 6 days. Clinical signs and symptoms of herpes including pain, itching, color change, and bleeding and also the duration of treatment period were recorded, and ulcer size was measured with a disposable folding ruler before, 3, and 6 days after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808092652N1
Registration date:2010-01-21, 1388/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-21, 1388/11/01
Registrant information
Name
Bahram Delfan
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66162001500
Email address
delfan.b@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Deputy of research
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-10-23, 1388/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical olive leaf extract 2% and topical acyclovir 5% on facial herpes simplex
Public title
The effect of topical olive leaf extract 2% and topical acyclovir 5% on facial herpes simplex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having facial herpes simplex, willingness to participate in the study and sign a written consent
Exclusion criteria: Participation in drug therapy including corticosteroids, antiviral drugs and immunosuppressive drugs, immune deficiency, metabolic, chronic, or serious systemic illnesses, simultaneous participation in another research, hypersensitivity to antivirus drugs
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Lorestan University of Medical Sciences
Street address
5th km of Boroojerd Road, Khorram Abad, Lorestan
City
Khorram Abad
Postal code
Approval date
2009-05-02, 1388/02/12
Ethics committee reference number
896
Health conditions studied
1
Description of health condition studied
herpes simplex facialis
ICD-10 code
B00.1
ICD-10 code description
Herpesviral vesicular dermatitis
Primary outcomes
1
Description
Pain
Timepoint
before treatment, 3 and 6 days after treatment
Method of measurement
severity of pain was scaled by Mcgill-Melzak method
2
Description
Itching
Timepoint
before treatment, 3 and 6 days after treatment
Method of measurement
by Mcgill-Melzak method
3
Description
Success of treatment
Timepoint
3 and 6 days after treatment
Method of measurement
percentage of cured patients
4
Description
Lesion size
Timepoint
before treatment, 3 and 6 days after treatment
Method of measurement
Using a disposable folding ruler
5
Description
Bleeding
Timepoint
before treatment, 3 and 6 days after treatment
Method of measurement
Presence of bleeding
6
Description
Color change
Timepoint
before treatment, 3 and 6 days after treatment
Method of measurement
color change comparing to the skin
7
Description
Side effects
Timepoint
3 and 6 days after treatment
Method of measurement
based on patient's complaint
Secondary outcomes
empty
Intervention groups
1
Description
A thin layer of topical ointment of olive leaf extract 2% were applied 5 times per day for 6 days
Category
Treatment - Drugs
2
Description
A thin layer of topical cream of Acyclovir 5% were applied 5 times per day for 6 days
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Ashayer Hospital
Full name of responsible person
Street address
City
khorram Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hasan Kaedi
Street address
Deputy of Research, Lorestan University of Medical Sciences , Shafa St.,
City
Khorram Abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Bahram Delfan
Position
academic member, Ph.D in pharmacology
Other areas of specialty/work
Street address
5th km of Boroojerd Road, Khorram Abad, Lorestan
City
Khorram Abad
Postal code
Phone
+98 66 1620 0150
Fax
+98 66 1620 0149
Email
delfan.b@lums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Bahram Delfan
Position
Acaedemic member, Ph.D in Pharmacology
Other areas of specialty/work
Street address
5th km of Boroojerd Road, Khorram Abad, Lorestan
City
Khorram Abad
Postal code
Phone
+98 66 1620 0150
Fax
+98 66 1620 0149
Email
delfab.b@lums.ac.ir bdelfan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Bahram Delfan
Position
academic member, Ph.D in pharmacology
Other areas of specialty/work
Street address
5th km of Boroojerd Road, Khorram Abad, Lorestan
City
Khorram Abad
Postal code
Phone
+98 66 1620 0150
Fax
+98 66 1620 0149
Email
delfan.b@lums.ac.ir bdelfan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)