Comparison of the effect of standard antibiotic treatment and antibiotic treatment adding vaginal honey in In patients with cervicitis who referred to Mousavi Hospital in Zanjan
Determine and comparison of the effect of standard antibiotic treatment and antibiotic treatment adding vaginal honey in In patients with cervicitis who referred to Mousavi Hospital in Zanjan
Design
Clinical trials with control group, community based and performance with parallel, double blind, randomized groups, and 51 subjects in each group.
Settings and conduct
This is a double-blind randomized clinical trial that was performed in all patients with cervicidity referred to Ayatollah Mousavi Hospital in Zanjan. In this study, the researcher and patient were blinded.
Participants/Inclusion and exclusion criteria
Include criteria: women non-pregnant -Having symptoms and clinical findings of cervicitis -age of 15-45 years
Exclude criteria:
Honey sensitivity
Abnormal Pap Smear
Antibiotic use in the last two weeks
PID
Diseases such as diabetes and immune deficiency
Consumption of corticosteroids
Intervention groups
Placebo and antibiotic groups: Placebo formulation was used for 5 days each night with an applicator for 2 weeks. Antibiotic therapy in both groups included oral azithromycin per gram of single dose and oral single dose 400 mg oral cefaxime with sexual partner therapy.
Vaginal honey group and antibiotic: Honey formulation was used every 5 days with an applicator for 2 weeks. Antibiotic therapy in both groups included oral azithromycin, one gram of single dose, and single dose 400 mg oral cefaxime with sexual partner therapy.
Main outcome variables
Pain intensity; Erosion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N3
Registration date:2018-10-12, 1397/07/20
Registration timing:retrospective
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-25, 1396/11/05
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
2018-01-25, 1396/11/05
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
2018-04-20, 1397/01/31
Scientific title
Comparison of the effect of standard antibiotic treatment and antibiotic treatment adding vaginal honey in In patients with cervicitis who referred to Mousavi Hospital in Zanjan
Public title
Comparison of the effect of standard antibiotic treatment and antibiotic treatment adding vaginal honey in In patients with cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women non-pregnant
Having symptoms and clinical findings of cervicitis
age of 15-45 years
Exclusion criteria:
Honey sensitivity
Abnormal Pap Smear
Antibiotic use in the last two weeks
PID
Diseases such as diabetes and immune deficiency
Consumption of corticosteroids
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
102
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to the two groups of 50 recipients of antibiotic and vaginal honey and other group antibiotic and placebo using the Select (randbetween (1; 2) command, using the Excel computer program).
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are similar and the third partner is planning to provide the students with a post-training course on how to use and how to complete the drug questionnaire. This person does not know the contents inside which group is concerned so neither the researcher nor the participants knows the contents of the package and the person will be blinded to the two sides.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Blvd, Zanjan University of Medical Sciences
City
زنجان
Province
Zanjan
Postal code
4515613191
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.ZUMS.REC.1396.270
Health conditions studied
1
Description of health condition studied
Cervicitis
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
Primary outcomes
1
Description
pain intensity
Timepoint
Before intervention and 21 days after intervention
Method of measurement
Based on the Visual Analuoge Scale pain intensity
2
Description
Erosion examination
Timepoint
Before intervention and 21 days after intervention
Method of measurement
Take a picture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The capsule Azythromycin is receiving 1g capsules single dose and Tablet Cefixime 400mg single dose and vaginal Gel of honey formulation per night 5 cc for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: the capsule Azythromycin is receiving 1g capsules single dose and Tablet Cefixime 400mg single dose and vaginal Gel of Placebo formulation is receiving per night 5 cc for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
gynecological clinic of Mousavi Hospital in Zanjan
Full name of responsible person
Nazanin Soltani
Street address
Gavazang Ave, Mousavi Hospital
City
زنجان
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3313 0001
Email
dr.nazaninsoltani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Azadi Blvd, Zanjan University of Medical Sciences
City
زنجان
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Nazanin Soltani
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Blvd, Zanjan University of Medical Sciences
City
زنجان
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
dr.nazaninsoltani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nazanin Soltani
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Blvd, Zanjan University of Medical Sciences
City
زنجان
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
dr.nazaninsoltani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Email
en.jenabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Any analysis on the data is pertinent with the source.
From where data/document is obtainable
Zanjan University of Medical Sciences
What processes are involved for a request to access data/document