Comparison of the effects of violet plant vaginal gel and metronidazole vaginal tablets in the treatment of Trichinosis vaginal infection.
Design
Eligible women for the study are using the permutation block method, 10 blocks of 8 are allocated to two groups of violet plant vaginal gel (40 people) and metronidazole tablets (40 people).
Settings and conduct
It will be done in women referring to health care center number 10 and women's clinic of Imam Khomeini Hospital affiliated to Ahvaz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Married women aged 15-45
Having a complaint of discharge
Diagnosis of Trichomonas vaginalis by clinical examination and laboratory tests (wet slide)؛
pregnant women
Lactating women
It is possible to start menstruation in the next 10 days
Abnormal and unknown vaginal bleeding
Sexual intercourse in the last 48 hours
Use of vaginal drugs in the last 48 hours
Use of immunosuppressive drugs
Use of broad-spectrum antibiotics
Diagnosis of bacterial vaginosis or candida albicans in vaginal secretions
Intervention groups
The present study will be a randomized clinical trial intervention with the aim of comparing the effect of violet plant vaginal gel with metronidazole tablets on the treatment of Trichomonas vaginalis infection in women referred to Health Care Center No. 10 and Women's Clinic of Imam Khomeini Hospital affiliated to Ahvaz University of Medical Sciences. , it is going to happen.
Main outcome variables
Improvement of foamy secretions؛ improvement of vulva and vaginal mucosa irritation؛ improvement of dyspareunia؛ improvement of cervical inflammation؛ improvement of the door under the heart؛ Lack of visibility of Trichomonas flagellate parasite under the microscope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240529061938N1
Registration date:2024-06-10, 1403/03/21
Registration timing:prospective
Last update:2024-06-10, 1403/03/21
Update count:0
Registration date
2024-06-10, 1403/03/21
Registrant information
Name
Agni broomand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 9144
Email address
agni.broomand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of violet plant vaginal gel and metronidazole tablet on treatment of trichomonas vaginalis
Public title
Comparison of the effect of violet plant vaginal gel and metronidazole tablet on treatment of trichomonas vaginalis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women 15-45 years old
Sexually active women
Having a complaint of discharge
Diagnosis of Trichomonas vaginalis by clinical examination and laboratory tests (wet slide).
Exclusion criteria:
pregnant women
Lactating women
It is possible to start menstruation in the next 10 days
Abnormal and unknown vaginal bleeding
Sexual intercourse in the last 48 hours
Use of vaginal drugs in the last 48 hours
Use of immunosuppressive drugs
Use of broad-spectrum antibiotics
Diagnosis of bacterial vaginitis or candida albicans in vaginal secretions
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Among the women who complained of vaginal discharge and referred to health centers No. 10 affiliated to Ahvaz University of Medical Sciences and the women's clinic of Imam Khomeini Hospital in Ahvaz and met the criteria for entering the study, they were selected and randomly divided into treatment groups. Using the permutation block method, 10 blocks of 8 are assigned to two groups of violet plant vaginal gel (40 people) and metronidazole tablets (40 people) using a random number table.
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
Jundishapur University of Medical Sciences, Ahvaz
Street address
No. 43, West third unit, No. 43, Shadalavi alley, Kadous intersection, Mehran Sajdei South street, Tehranpars
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.AJUMS.REC.1403.092
Health conditions studied
1
Description of health condition studied
trichomonas vaginalis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Primary outcomes
1
Description
trichomonas vaginalis
Timepoint
After one week after the end of taking the medicine to check the effect of treatment and after 4 weeks after the end of taking the medicine to check the recurrence of infection by observation and examination and examination of secretions and recording in the form of observation and examination after treatment
Method of measurement
wet slide
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Violet plant vaginal gel؛ First, by placing a speculum, the shape, consistency, size and color of the vaginal secretions are evaluated, and the results of the examinations and observations will be recorded in the pre-treatment form. Then some of the vaginal discharge is placed on a slide with a swab and examined under a microscope for the presence of motile trichomonas. Violet plant vaginal gel is made by a trusted pharmacist of Ahvaz University of Medical Sciences and a design consultant, in such a way that hydroxypropyl methyl cellulose (HPMC) and ethyl cellulose (EC) powders are mixed separately with propylene glycol and triethanolamine. . Then the formula is dispersed in two thirds of water. Methylparaben and extract powder are mixed in the rest of the formula water and finally added to the prepared gel and finally the following tests are performed to measure the prepared gel and the best formulation is selected for conducting clinical studies. Samples of the formulations are stored in an incubator with a temperature of 50 degrees Celsius, a refrigerator and an ambient temperature, and during the storage period, they are examined for color, smell, and consistency on specific days. In order to determine the pH, a mixture of 1 part of gel in 9 parts of water is prepared and the pH of the resulting mixture is determined by a pH meter. After delivering the medicine to the volunteers, they will be taught how to use it and how long to use it, and how to use the applicator. Also, to the volunteers to refer again after one week after finishing the medication to check the effect of treatment and after 4 weeks after finishing the medication to check the recurrence of infection by observation and examination and examination of secretions and registration in the observation and examination form. It will be taught after treatment. Teaching tips such as avoiding sexual intercourse or using condoms during the treatment period and not using other drugs at the same time during the treatment will be taught. The candidate will be asked to record any side effects of the treatment in a checklist. To ensure that the instructions are followed correctly, the researcher will communicate with the patients during the treatment. In the follow-up visit of the patient, in terms of lack of secretions and pain under the heart, burning of mucus and reduction of inflammation of the cervix and vagina, and lack of visibility of flagellated trichomonas parasite under the microscope, it will be checked as an effective treatment, and the result of the observations will be recorded in the observation form.
Category
Treatment - Drugs
2
Description
Control group: metronidazole tablets; Metronidazole 500 mg tablets will be taken 2 times a day for 7 days. And the patient's history is evaluated in three stages.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Clinic of Imam Khomeini Hospital
Full name of responsible person
Zahra Abbaspoor
Street address
24 Meter St., Azadegan Blvd., Ahvazian St
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3222 2818
Email
abbaspoor-z@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Health center number 10
Full name of responsible person
Zahra Abbaspoor
Street address
, Farhangshahr, Farhangshahr, Rushd 6th Street, Security Street
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3332 8375
Email
abbaspoor-z@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mernoosh Zakerkish
Street address
Golestan highway-Jandishapur Ahvaz University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
Golestan highway-Jandishapur Ahvaz University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
abbaspoor-z@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Reproductive Health
Street address
Golestan highway-Jandishapur Ahvaz University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
abbaspoor-z@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Agni Boroomand
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
2nd floor of Tehranpars, Festival Street, Kados Crossroad, Mehran Sajdei South Street, Shadalavi Alley, No. 43, Third West Unit
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 7788 9144
Email
agni.broomand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to expand the collected results and any type of analysis that is not considered manipulation of the data
From where data/document is obtainable
Agni Broomand: agni.broomand@gmail.com
What processes are involved for a request to access data/document
After going through the verification process, the data will be provided as soon as possible.