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The Effect of Honey Ointment on the Pain Severity and Healing of Women Genital Herpes Lesions.

Protocol summary

Study aim
Comparison of pain severity in two groups of intervention and control before, 7 and 10 days after treatment. Comparison of lesions healing in two groups of two groups of intervention and control before, 7 and 10 days after treatment.
Design
A randomized controlled clinical trial with parallel groups, Triple-blind, four-block randomized block
Settings and conduct
The Research Environment is the dermatology clinic of Razi Hospital and Imam Khomeini Hospital. 68 of women who referred to this center and their wounds were diagnosed herpes by a doctor, will be divided into two groups using 4-block randomized method. The severity of pain and stage of lesion will be recorded and repeated on days 0, 7 and 10. How to get blind is that the researcher, the participents , and the statistics consultant are unaware of the type of drug being administered, and both drugs are provided in identical formats and with specific codes by the pharmacist.
Participants/Inclusion and exclusion criteria
Initial Herpes Genital Needs treatment for active Wounds Non-use of effective medications for Wound Healing (Anticoagulants, Anti-depressant, Alcohol, Glucocorticoids, immunosuppressive drugs, Chemotherapy, drugs, Psychotropic drugs) Lack of disease that disrupts Wound Healing (Chronic systemic diseases, Heart disease, kidney disease, Lung disease, Coagulopathy, Immune deficiency,Connective tissue disorder, Diabetes, Anemia, mental illnesses, hemophilia, Depression, Malnutrition) Lack of Pregnancy or Lactation
Intervention groups
Intervention group: Oral Aciclovir 400 mg 3 times daily with honey ointment 5 times daily. Control group:Oral Aciclovir 400 mg 3 times daily with placebo ointment 5 times daily.
Main outcome variables
Severity of pain Healing of lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160821029446N6
Registration date: 2020-03-24, 1399/01/05
Registration timing: prospective

Last update: 2020-03-24, 1399/01/05
Update count: 0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Honey Ointment on the Pain Severity and Healing of Women Genital Herpes Lesions.
Public title
The Effect of Honey Ointment on the Pain Severity and Healing of Women Genital Herpes Lesions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Initial Herpes Genital Needs treatment for active Wounds Non-use of effective medications for Wound Healing (Anticoagulants, Anti-depressant, Alcohol, Glucocorticoids, immunosuppressive drugs, Chemotherapy, drugs, Psychotropic drugs) Lack of disease that disrupts Wound Healing (Chronic systemic diseases, Heart disease, kidney disease, Lung disease,  Coagulopathy, Immune deficiency,Connective tissue disorder,  Diabetes, Anemia, mental illnesses, hemophilia, Depression,  Malnutrition) Lack of Pregnancy or Lactation
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into two groups of intervention and control, so that we first design 4 blocks of different types of probability, so that in each block two of the intervention group and two of the control group will be placed. The number of possibilities in this case will be 6. Then create a list of random numbers between 1 and 6 and arrange the blocks according to the list of numbers obtained until the total number of samples is covered. Accordingly, individuals are divided into two groups. The intervention group will be the group that will take oral acyclovir with honey ointment and the control group will be the group that will take oral acyclovir with placebo.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This Study will be a Randomized Controlled Trial, Triple-blind, Placebo-Controlled Clinical Trial. The Drugs are already divided by the Pharmacist. How to get Blind is that the Participants, the Researcher, and the Statistics Consultant are Unaware of the Type of Drug being Administered, and both Drugs are provided in identical formats and with specific codes by the Pharmacist and are provided to research units. Participants and Researcher will not be aware of the Drug codes, only the Pharmacist will determine the Drug code, and will be decrypted after the Data is collected and completed. The dose of Acyclovir in both groups will be the same as prescribed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medical
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-02-12, 1398/11/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.172

Health conditions studied

1

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

Primary outcomes

1

Description
Severity of Pain
Timepoint
At the beginning of the study and 7 and 10 days after intervention
Method of measurement
VAS tool

2

Description
Healing of lesions
Timepoint
At the beginning of the study and 7 and 10 days after intervention
Method of measurement
Observation and Ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with honey ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10.
Category
Treatment - Drugs

2

Description
Control group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with Placebo ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com

2

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maryam Damghanian
Street address
Razi Dermatology Specialty Hospital, Razi Dead End, Vahdat-e-Eslami Square, Vahdat-e-Eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5563 0174
Fax
+98 21 5562 0300
Email
maryam_damghanian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No23, Dameshgh street, Valiasr street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Tehran University of Medical Sciences
Full name of responsible person
Shahnoush Gerami
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences, Tohid Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
sh.gerami1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty,Tehran University of Medical Sciences,Tohid Square,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Fax
Email
Maryam_damghanian@ yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty,Tehran University of Medical Sciences,Tohid Square,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Fax
Email
Maryam_damghanian@ yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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