To Identify the effectiveness of Oral Ferula Capsul and Oral Metronidazole Pill on Terichomonas vaginalis infection Treatment
Design
This study is conducted on two parallel groups on 60 women in the
intervention group 1 and 2. Metronidazole tablets are prescribed for one group and Ferula capsuls are prescribed for another one. In order to keep the ethics of the study, samples should cooperate voluntarily and by random.
Settings and conduct
health tips and the way the medicine should be consumed are taught to both groups in DIC centers and Qa'im and Um al-Banin gynecologic clinics. One group should use 500-mg oral metronidazole tablets and the other should use 250-mg oral capsule twice a day for a period of 7 days. Then, within 2 to 7 days after the completion of the medication, if there is no menace, a laboratory examination of the treatment success is measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All Iranian women who are married and non-pregnant, who have sex with their spouse and who have clinical and laboratory symptoms of Trichomonas vaginalis infection, are not allergic to metronidazole and Appiaceae.
Intervention groups
500-mg Metronidazole tablets and 250-mg Ferula capsules are prepared from the angiogenesis and after getting consent letter and a full explanation of the therapeutic method for the intervention groups 1 and 2, metronidazole tablets or capsules are given and they are asked to consume them every 12 hours. Health tips and methods of using the medication are taught to both groups, and a 500 mg oral metronidazole tablet is given to one group and oral Ferula capsule will be given to the another one. Both groups should consume medicine the twice a day.
Main outcome variables
Negative result of vaginal mucus in wet smear considering Trichomoniasis parasite and the negative sign of trichomoniasis clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190220042776N1
Registration date:2019-04-01, 1398/01/12
Registration timing:prospective
Last update:2019-04-01, 1398/01/12
Update count:0
Registration date
2019-04-01, 1398/01/12
Registrant information
Name
Sara Bagherinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
bagherinasabs961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effects of Oral Ferula Capsul and Oral Metronidazole Pill on Terichomonas Vaginalis Infection Treatment
Public title
The Effects of Oral Metronidazole Pill on Trichomonas Vaginalis Infection Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
To cooperate willingly
Having at least the ability of reading and writing
Being married
Having sexual relationship with her spouse
Not having Pelvic inflammatory disease (PID)
She should use condom during the course of treatment
Having no particular medical condition
The total score for signs and symptoms of Trichomonas vaginalis is at least 1 in the examination and interview
A wet specimen test being positive for Trichomoniasis
Not having recurrent Trichomoniasis
Exclusion criteria:
Having sex without using condom during treatment
There is no history of allergy to oral metronidazole tablets and Appiaceae
Not using antibiotics or anti-parasites within two weeks
Having abnormal uterine bleeding (AUB / DUB)
Not using the treatment for one day or using twice a day
Being pregnant
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize easily and easily
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To keep the ethics of the study, firstly, the written permission must be obtained from the ّFerula group voluntarily so there is no possibility of blindness and semi-experimental study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research of Mashhad University of Medical Science
Street address
Ibn Sina/ faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.090
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 infectious and parasitic diseases classified elsewhere
Primary outcomes
1
Description
Negative result of Vaginal mucus test smear test of woman with Trichomonas vaginal infection
Timepoint
2 and 7 days after the completion of the medication if it the person does not have period, otherwise if the sample experiences a monthly pattern after the end of the period
Method of measurement
Vaginal mucus wet smear test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Health Tips and Appropriate medicine consumption (twice a day, for seven days every 12 hours) are taught. Oral pills 500 mg of metronidazole is prescribed. After the completion of the medication the negative smear test is needed if the samples are not experiencing Period. If the sample experiences a monthly pattern, the test is done after its end.
Category
Treatment - Drugs
2
Description
Intervention group2: The samples enter the group voluntarily. Health Tips and Appropriate medicine consumption (twice a day, for seven days every 12 hours) are taught. Oral pills 250mg of Ferula capsule is prescribed. After the completion of the medication the negative smear test is needed if the samples are not experiencing Period. If the sample experiences a monthly pattern, the test is done after its end.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
DIC center and Women's Clinic of Qa'im and Um Al-Benin Hospital
Full name of responsible person
Mahin Tafazoli
Street address
Ibn Sina street - Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
m_bagherinasab@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Street address
Ibn Sina- faculty of nursing and midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
m_bagherinasab@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sara Bagherinasab
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
39کاشمر /خیابان گلستان 4 /پلاک
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 5523 5570
Email
m_bagherinasab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Bagheri nasab
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ibn Sina / faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 5523 5570
Email
M_bagherinasab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Bagherinasab
Position
Master student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ibn Sana - faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 5523 5570
Email
m_bagherinasab@yahoo.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