Comparison of treatment with oral metronidazole vaginal cream Prangos ferulacea with oral metronidazole vaginal cream with placebo in the treatment of Trichomonas vaginalis infection in women
Determine the effect of Prangos ferulacea vaginal cream on accelerating the improvement of Trichomonas vaginalis.
Design
By target and target sampling, in 2018, 90 people will be randomly divided into two groups of 45 people.
Settings and conduct
was carried out in clinics affiliated with Lorestan University of Medical Sciences in women with diagnosis of trichomoniasis, based on patient complaints, clinical observations and wet and colored microscopic tests. Clinical observations and wet microscopic and staining tests are reviewed within 7 days of treatment. Data were analyzed using independent t-test, chi-square, exact Fisher, Mann-Whitney and McNemar with a significant level (p <0.05).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-pregnant women 15 to 49 years old; Married non-lactating non-menopausal; Claimant from vaginal discharge; Regular menstrual cycles; Non-vaginitis; Non-use of vaginal or antibiotic drugs during the past 2 weeks; Non-participation in Other research studies over the past four weeks; no cervical dysfunctions; no chronic medical conditions and willing to participate in the present study (with informed written consent).
Exit criteria: Unwillingness at each stage of the research, no drug use for one night; sexual intercourse; pregnancy; having menstrual bleeding and non-timely referral.
Intervention groups
Intervention group: Metronidazole tablets 250 mg, 500 mg orally twice daily (every 12 hours) with food for 7 days with Prangos ferulacea vaginal cream for 7 days. Control group: oral metronidazole 250 mg Grams, 500 mg twice daily (every 12 hours) with food for 7 days, together with placebo vaginal cream.
Main outcome variables
Direct vaginal observation (foamy yellowish discharge); Vaginal pH; Visum test; and microscopic observation of stained slides before and 7 days after treatment.
General information
Reason for update
Acronym
TVI
IRCT registration information
IRCT registration number:IRCT20160423027534N2
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Asieh Azadpourmotlagh
Name of organization / entity
(International Branch), Faculty of Nursing & Midwifery, Shahid Beheshti University of Medical Scienc
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 9020
Email address
azadpurmotlagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
empty
Scientific title
Comparison of treatment with oral metronidazole vaginal cream Prangos ferulacea with oral metronidazole vaginal cream with placebo in the treatment of Trichomonas vaginalis infection in women
Public title
The effect of vaginal cream Prangos ferulacea Brghvnt Trichomonas vaginalis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: 15-49 year old married women
Non pregnant
Non breast feeding
Non menopause
Non smoker
Willing to participate in the research
Complaine with foamy yellow green discharge
Not having vaginal infections
Not having unusual vaginal bleeding during the treatment
Not intercoursing during the treatment
Not using vaginal ointment,suppository or douching from two days before treatment
Not having chronic diseases like heart or kidney problems, diabetes, arthoritis
Not using broad-spectrum antibiotics, hormones, anticoagulant and immunosuppressive medicine
Not having allergic to metronidazole or topical medications
Exclusion criteria:
Exclusion criteria: Unwilling to continue to participate in the reseach
Not using vaginal ointment for two consecutive days
Being allergic to metronidazole or Prangos ferulacea vaginal cream or intolerance to any forms of medicine
Having vaginal infections (bacterial vaginosis and candidiasis)
having intercourse during in the treatment
become pregnant during treatment
incomplete questionnaire
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Available (simple) based on the target.
In this way, all patients who have conditions of entry to the study, are examined. The delivery of drugs to patients is such that, in a box, a number of cards matching them equally, the letters of the English alphabet "A A" and "B" correspond to the vaginal cream code of the placebo and Prangos ferulacea (the researcher does not know the worms' content), and Patients randomly select a card and deliver the medicine according to the letters on the card.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a randomized, triangular blind clinical trial. The diagnosis of Trichomonas slides be encoded and the patient's name is not written. At the stage of giving the patient, the Prangos ferulacea vaginal cream and placebo are marked with the English letters A and B, which are coded by the pharmacist. The researcher is unaware of its contents, and the patient will randomly choose one of the vaginal creams. In the referral stage after treatment, the slides are also examined by another researcher. And the professor of statistics is also unaware of the control and intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee of Ethics in Biomedical Research
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.SBMU.REC.1397.018
Health conditions studied
1
Description of health condition studied
Trichomoniasis vaginit
ICD-10 code
A59.01
ICD-10 code description
Trichomonal vulvovaginitis
Primary outcomes
1
Description
1- Evaluation of vaginal secretions in terms of color, odor by direct observation.2. Transient trichomoniasis (under microscope) in wet smear.
Timepoint
Before interference and 7 days after treatment
Method of measurement
At first, the secretions and symptoms will be examined with direct vision. Then, using sterile cotton swabs, a vaginal discharge was taken and a 10% potassium solution was prepared on a lavender discharge prepared with sterile cotton swabs. And immediately poured a drop of saline samples under a microscope with a magnification of 400 (× 40) was seen moving trophozoite information.
2
Description
Observe the wet slides with a microscope
Timepoint
Before interference and 7 days after treatment
Method of measurement
With sterile cotton swabs, a sample of the secretions of the side walls of the vagina was removed and immediately underneath the microscope with magnification (× 40). If trichomoniasis is present in wet pearl trophozoites, they are approved.
Secondary outcomes
1
Description
Trichomoniasis vaginitis
Timepoint
En Before the intervention, seven days after start treatment.
Method of measurement
Samples are discharge from the sample by using the pH meter Strip, and after wetting the pH Strip, the color will change, and if the pH of the vaginal discharge is between 6-5, a wet test is performed.
Intervention groups
1
Description
Intervention group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our Prangos ferulacea vaginal cream.
Category
Treatment - Drugs
2
Description
Control group:metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers affiliated to Lorestan University of Medical Sciences( Khorramabad city)
Full name of responsible person
Asieh Azadpourmotlagh, Master of Midwifery
Street address
Health centers affiliated to Lorestan University of Medical Sciences( Khoramabad city).
City
Khoramabad
Province
Lorestan
Postal code
6814738789
Phone
+98 21 8820 2521
Fax
Email
azadpurmotlagh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahrokh Dolatian.
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
mhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asieh Azadpourmotlagh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
azadpurmotlagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asieh Azadpourmotlagh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
azadpurmotlagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asieh Azadpourmotlagh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
azadpurmotlagh@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