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Investigation Of The Effect Of Herbix compound In The Treatment Of Facial Herpes.

Protocol summary

Study aim
.Determining the effect of Herbix combination in the treatment of facial herpes
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized, phase 2 for 10 patients.
Settings and conduct
.Patients are introduced to Targaba health network and. Before starting the treatment, a blood sample and wound tissue sample, real time PCR and a photo of the wound will be taken. One drop of Herbix medicine will be used on the wound. Follow-up will be done for one month. Demographic and clinical information will be collected from the case, test and observation. After one month, the blood test will be repeated and a photo will be taken of the place where the herpes has healed. In this study, we will investigate the variables of HDF, 8-OH-dG, HSV-1 gene, caspase-3 gene, caspase-9 gene, and Anti-Herpes cytotoxicity.
Participants/Inclusion and exclusion criteria
Clinical Lyme Herpes such as tingling and itching around the wound Small blisters filled with liquid on the skin of the face Scaling of small merged blisters Fluid secretion
Intervention groups
5 control group patients have facial herpes sores will receive only the selected drug Acyclovir (the same drug as the doctor's opinion) and for the intervention group, 5 patients will receive the drug Acyclovir in addition to Herbix.
Main outcome variables
.Herbix, HDF fibroblast cell, 8-OH-dG, HSV-1 gene, caspase-3 gene, caspase-9 gene, Anti-Herpes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231030059908N2
Registration date: 2023-12-25, 1402/10/04
Registration timing: prospective

Last update: 2023-12-25, 1402/10/04
Update count: 0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Fateme Mollazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 4944
Email address
f.mollazade1159@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation Of The Effect Of Herbix compound In The Treatment Of Facial Herpes.
Public title
Herbix compound In The Facial Herpes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical symptoms of herpes such as tingling and itching around the wound. Small blisters filled with liquid on the skin of the face. Scaling of small merged blisters. Fluid secretion.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Care provider
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
.In this study, the clinical caregivers of this doctor and her assistants.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Mashhad Unit
Street address
Mashhad, 14 Imam Khomeini Street, Faculty of Medicine, Azad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2023-11-19, 1402/08/28
Ethics committee reference number
IR.IAU.MSHD.REC.1402.135

Health conditions studied

1

Description of health condition studied
herpes simplex
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
RNA extraction
Timepoint
At the beginning of the study, on the thirtieth day.
Method of measurement
HDF fibroblast cell, 8-OH-dG, HSV-1 gene, caspase-3 gene, caspase-9 gene, Anti-Herpe

2

Description
Real-time Polymerase chain reaction investigation
Timepoint
At the beginning of the study, on the thirtieth day
Method of measurement
Commercial kit of Ben Yakhte company

3

Description
Antiviral antibody level in serum
Timepoint
At the beginning of the study, on the thirtieth day
Method of measurement
ELISA technique and abCAM company kit

4

Description
DNA damage
Timepoint
The beginning of the study
Method of measurement
8-OH-dG level in culture supernatant

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the standard treatment for Herpes Simplex, this group receives a new drug called Herbix
Category
Treatment - Drugs

2

Description
Control group:They receive only the standard drug, acyclovir
Category
Treatment - Drugs

3

Description
Intervention group: Intervention group: After confirming the effect of Herbex drug, this time patients will only receive Herbix drug.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Gholamreza Karamatian
Street address
Ebn Sina Street, Imam Reza Square, Imam Reza Hospital, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
1708534
Phone
+98 51 3854 3031
Email
info@scanteb.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Keramatiyan
Street address
48, Abdulmutallab, Shahid Qorani Blvd. Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9196664944
Phone
+98 51 3607 1468
Email
keramatiyanGH1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Keramatiyan
Position
Non-faculty general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
48, Abdulmutallab, Shahid Qorani Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9196664944
Phone
0098513529717
Email
keramatiyanGH1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamadreza KHakzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Rezashahr, No. 83, Daabel Khazai 2, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177773435
Phone
+98 51 3225 0041
Email
MR.khakzad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
No.8/Alaleh Ave/ Pirouzi Blvd/ Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176982756
Phone
+98 51 5523 4944
Fax
Email
f.mollazade1159@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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