Evaluate healing effect of honey on erosions caused by colposcopy and biopsy in ASC-H
Design
In this research, 60 patients referring to oncology clinic were chosen purposefully and a code was allocated to each one of them. Then, patients will divided into two control and intervention groups depending on even/odd day.
Settings and conduct
This study evaluates healing effect of honey on erosions caused by colposcopy and biopsy in ASC-H at oncology clinic of Fatemieh hospital, Hamadan. Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Participants/Inclusion and exclusion criteria
Including criteria: Papsmear ASC-H
Excluding criteria: Any immune deficiency; cigarette smoking; any chronic disease that interfere with wound healing such as DM; medication usage that interfere with wound healing: corticosteroids; anticoagulants immunosuppressant and chemotherapy.
Intervention groups
Intervention group: Patients who receive honey gel twice a day for one week
control group: Patients who receive placebo gel twice a day for one week
Main outcome variables
Healing of lesion caused by colposcopy and biopsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030517N1
Registration date:2017-12-29, 1396/10/08
Registration timing:registered_while_recruiting
Last update:2017-12-29, 1396/10/08
Update count:0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
rahil askari nejad behzadi
Name of organization / entity
Hamedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 4011
Email address
r.asgari@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-01-19, 1396/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating healing effect of honey sitz bath on erosions caused by colposcopy in patients with ASC-H in papsmear
Public title
healing effect of honey on erosions caused by colposcopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred for evaluation by colposcopy due to ASC-H in pap smar
Exclusion criteria:
Any immune deficiency; cigarette smoking; any chronic disease that interfere with wound healing such as DM; medication usage that interfere with wound healing: corticosteroids; anticoagulants immunosuppressant and chemotherapy.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-04-07, 1396/01/18
Ethics committee reference number
IR.UMSHA.REC.1396.36
Health conditions studied
1
Description of health condition studied
ASC-H
ICD-10 code
R87.611
ICD-10 code description
•Atypical squamous cells on cervical Papanicolaou smear cannot exclude high grade squamous intraepithelial lesion
Primary outcomes
1
Description
Healing of erosions caused by colposcopy
Timepoint
One and two weeks after treatment
Method of measurement
In weekly visits of patients; erosions are evaluated and the healing staging is done with qualitative measures: totally repaired; partially repaired; no change.
Secondary outcomes
1
Description
Evaluating erosion healing in case and control group
Timepoint
One and two weeks after treatment
Method of measurement
in 3 qualitative groups: totally repaired; partially repaired; no change.
2
Description
Evaluating cervical colposcopic status
Timepoint
First visit, one and two weeks after treatment
Method of measurement
With Reids colposcopic index: cervical intraepithelial neoplasia 1, 2, 3
Intervention groups
1
Description
In intervention group Doxycycline cap 100 mg PO bid given for 5 days; and honey gel 10% 10 cc vaginally given for a week.
Category
Treatment - Drugs
2
Description
In control group Doxycycline cap 100 mg PO bid given for 5 days; and placebo gel 10 cc given for a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Rahil Askari Nejad Behzadi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7459
Fax
+98 81 3828 3939
Email
Fatemieh@umsha.ac.ir
Web page address
http://fth.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
3253445642
Phone
+98 81 3255 8801
Email
webda@umsha.ac.ir
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Rahil Askari Nejad Behzadi
Position
OB and GYN resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3838 0755
Fax
Email
askary.rahil@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Rahil Askari Nejad Behzadi
Position
OB and GYN resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7459
Fax
Email
r.asgari@edu.umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Rahil Askari Nejad Behzadi
Position
OB and GYN resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3828 3939
Fax
Email
r.asgari@edu.umsha.ac.ir
Web page address
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