This study is a double-blind, randomized, single center, controlled trial on people aged 18 to 70 years old that are coming to Naghavi Hospital suffering from recurrent herpes labialis for less than 12 hours. Participants must not have used the antiviral drug in the past two weeks and must not have a history of immunotherapy over the last year or immune system stimulation in the last month. Other mucocutaneous disorders and a history of RAS are among exclusion criteria. There will be 80 participants randomly divided into two groups of herbal gel containing Prunella vulgaris extract or Acyclovir. A thin layer of both will be applied every 3 hours (6 times per day) to the lesion. The participants will be visited at baseline and six days after the start of the study and will be followed in the second and fourth day after the beginning of the study by telephone. Clinical information and severity of burning and itching, soreness, tingling, and other possible side effects of medications will be recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021412438N16
Registration date:2016-03-03, 1394/12/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal plants
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between gel containing Prunella vulgaris extract and Acyclovir on treatment of labial herpes in patients with recurrent herpes labialis
Public title
The effect of gel containing Prunella vulgaris extract on labial herpes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: People 18 to 70 years old with recurrent herpes labialis that Less than 12 hours have passed vesicate.
Exclusion criteria: Pregnancy and lactatin; use the antiviral drug in the past two weeks; have a history of immunotherapy in the last year; stimulating the immune system in the last month; Other mucocutaneous disorders; history of RAS ;history of allergy to the plant used in the study of allergic reaction during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics committee of Kashan University of Medical Sciences
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.KAUMS.REC.1394.148
Health conditions studied
1
Description of health condition studied
recurrent herpes labialis
ICD-10 code
B00.1
ICD-10 code description
Herpesviral vesicular dermatitis
Primary outcomes
1
Description
Clinical symptoms of blisters
Timepoint
Baseline and End-of-trial
Method of measurement
Observation
2
Description
Burning
Timepoint
At days 0, 2, 4, 7
Method of measurement
VAS
3
Description
Iitching
Timepoint
At days 0, 2, 4, 7
Method of measurement
VAS
4
Description
Soreness
Timepoint
At days 0, 2, 4, 7
Method of measurement
VAS
5
Description
Tingling
Timepoint
At days 0,2,4,7
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
intervention: topical herbal gel, 6 times a day (every 3 hours) for a week
Category
Treatment - Drugs
2
Description
control: topical acyclovir, 6 times a day (every 3 hours) for a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Hospital
Full name of responsible person
Dr Mohammad Hajijafari
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Km. 44 of Kashan - Delijan Rd, Mashhad-e- Ardehal Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
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 of Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
Postal code
Phone
+95 3155540021
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Km. 44 of Kashan - Delijan Rd, Mashhad-e- Ardehal Kashan
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)