The aim of this study was to evaluate the effect of propolis vaginal gel on trichomonas ectocervicitis.
Design
The clinical trial was performed on 112 patients in two equal groups of intervention (A) and control (B). This study was single blinded and randomization based on simple method
Settings and conduct
The ethical aspects of the study were investigated and confirmed by the Research Ethics Committee Isfahan University of Medical Sciences, and the necessary permissions were obtained. Participants who had the inclusion criteria enrolled in this one-blind study and randomization was conducted in intervention(A) or control(B) groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian nationality; age: 18-45 years old; being sexually active (be married); having one partner; not pregnant or lactating; not during menstruation period; positive wet smear in both of groups; gynecologist confirmation of diagnosis; not having a history of drug allergy; not having a history of using antibiotics or vaginal drugs for ectocervicitis treatment in last 1 months ago; not having a history of using hormonal and immunosuppressive drugs; not having a history of some diseases such as: chronic diabetes melitus, anemia, renal diseases, liver diseases, cardiovascular diseases and etc..; not having a history of pelvic surgery. Exclusion criteria: occurrence of any undesirable incidence; not referred for follow up visits; irregular used of drugs (two consecutive nights or three not-consecutive nights); using other antibiotic or palliative treatments; having sexual function without used of condom.
Intervention groups
Intervention group: this patient used the gel containing extract of propolis for 7 nights. The patient of control group and husband of both group used of metronidazol 500 mg tablet twice a day for 7 days.
Main outcome variables
Healing of trichomonas ectocervicitis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091219002889N10
Registration date:2019-12-22, 1398/10/01
Registration timing:registered_while_recruiting
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Mahboubeh Valiani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4640
Email address
valiani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-15, 1398/06/24
Expected recruitment end date
2020-01-14, 1398/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of proplis vaginal gel on trichomonas ectocervicitis.
Public title
Comparing the effect of proplis vaginal gel on trichomonas ectocervicitis in women referred to gynocologic clinics of Isfahan educational centers (2019).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race.
18-45 years old.
Be sexually active( married).
Had one sexual partner.
Not pregnant or lactating.
Not during menstruation period.
Positive wet smear in both groups.
A gynecologist confirmation of diagnosis.
Not having a history of drug allergy.
Not having a history of using antibiotics or vaginal drugs for ectocervicitis treatment in last 1 months ago.
Not having a history of using hormonal and immunosuppressive drugs.
Not having a history of some diseases such as: chronic diabetes melitus, anemia, renal diseases, liver diseases, cardiovascular diseases and etc...
Not having a history of pelvic surgery.
Exclusion criteria:
Not interested in participating in the study.
Not referred for follow up visits.
Irregular used of drugs (two consecutive nights or three not-consecutive nights).
Used of other antibiotics.
Used of other palliative treatment.
Having sexual function without used of condom.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized controlled trial was carried out. One group of women who refer to clinics on the odd days. (Group A); the other group (Group B) refer to clinics on even-number days.
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Azadi Blvd., Hezar jerib Ave., milad dorm.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.MUI.REC.1398.001
Health conditions studied
1
Description of health condition studied
exocervisitis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Primary outcomes
1
Description
Healing of trichomonas ectocervisiti.
Timepoint
Pre intervention,1 and 2 weeks after intervention
Method of measurement
Self-made questionnaire.
Secondary outcomes
1
Description
Healing of trichomonas ectocervisitis.
Timepoint
Preintervention,1 and 2 weeks after intervention
Method of measurement
Self-made questionnaire.
Intervention groups
1
Description
Intervention group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, received a vaginal gel containing 7.5% of propolis extract that prepared by Salafchegan Pharmaceutical Company, with seven sterile packaged applicators and 14 metronidazole tablets 500 mg for used by their spouses. Patients used of vaginal gel( half of the applicator) every night before bed for seven nights. At the same time, the intervention group's spouses were treated with metronidazole 500 mg twice a day (every 12 hours) for seven days. Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations.
Category
Treatment - Drugs
2
Description
Control group: if this patient had the inclusion criteria, after submitting a description and obtaining informed consent, receive 28 metronidazole 500 mg tablets for treatment of themselves and their spouses. The patients and their spouse used the drug twice a day (every 12 hours) for 7 days. Patients were advised to refrain from sexual intercourse during treatment and were given pamphlet-based health-nutrition recommendations.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Seyedeh Shadi Taghavian
Street address
Motahari Ave., Shahid Beheshti Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Fax
Email
Beheshti@mui.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Seyedeh Shadi Tghavian
Street address
Shohadaye soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
Alzahra@mui.ac.iA
Web page address
3
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Seyedeh Shadi Taghavian
Street address
Ibn sina Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3303 3400
Fax
Email
Amin@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Street address
Isfahan University of Medical Sciences, Hezar jerebAve., Azadi Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 2006
Email
jazb@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Shadi Taghavian
Position
MSc Student midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isfhan
City
Isfhan
Province
Isfehan
Postal code
8174673461
Phone
0098316689801
Email
Taqavianshadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboube Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isfahan University of Medical Science, Hezar jereb Ave., azadi Blvd.
City
Isfahan
Province
Isfehan
Postal code
8199939438
Phone
+98 31 3792 2936
Email
valiani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Shadi Taghavian
Position
MSc Student midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isfahan University of Medical Science, Hezar Jereb Ave., Azadi Blvd.
City
Isfahan
Province
Isfehan
Postal code
8173785737
Phone
+98 31 3792 3086
Email
Taqavianshadi@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