This research is conducted in order to follow the purpose of comparing the influence of
Vaginal suppository Phytovagex with edible Metronidazole on Bacterial vaginosis , and
this research will be done in the form of three random , triple–blind.These are the main criterions to be included : aged from 15 to 49, married, non-pregnant, and women coming to Mash ’had medical
center number 2 complaining of smelly vaginal secretions.Diagnostic criterions are the existence of three Amsel criterions:Grey hemogen secretions –positive wiff test –PH 4.5.Eligible candi dates will be placed into two groups (A and B) randomly.7 to 10 days after the treatment period , patients will be checked for the second time. The lack of the existence of the mentioned three Amsel criterions is considered as a successful cure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020320925N1
Registration date:2017-01-18, 1395/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Mahin Kiyani Mesk
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 8512
Email address
kianimm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Contribute 90 percent of Credit research contract enforcement And 10 percent of funding for evidence-based research center Faculty of Nursing and Midwifery, Mashhad
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of therapeutic success rate of Phytovagex vaginal suppository and oral Metronidazole on treatment of Bacterial vaginosis
Public title
Effect of Phytovagex vaginal suppository on Bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria:married;the age range between 30-18 years;no pregnant; IUD is not;during breastfeeding is not;Failure to perform hysterosalpangiography ,curettage and surgery of uterine in the past two weeks;absence of a history of sensitivity to oral metronidazole;broad-spectrum antibiotics and the immune system depressant drugs the past two weeks;lack of use of alcohol and anticoagulant drugs;absence of problems and anomalies of the cervix;the absence of pelvic inflammatory disease;the Absence of abnormal uterine bleeding (AUB or DUB) Exclusion criteria: Sensitivity to prescribed drug; take antibiotics (injectable, oral or vaginal) during the intervention; not using drug more than one time)
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Postal code
137913199
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.MUMS.REC.1394.322
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
Primary outcomes
1
Description
Amsel criteria
Timepoint
7-10 days after treatment
Method of measurement
Three Amsel criteria (homogeneous gray discharge, positive Whiff test 5.4PH≥)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Phytovagex vaginal suppository, a suppository every night for seven nights
Category
Treatment - Drugs
2
Description
Control group: oral metronidazole 250 mg tablets, two tablets every 12 hours for seven nights
Category
Treatment - Drugs
3
Description
Control group:placebo suppository every night for seven nights a vaginal suppository
Category
Placebo
4
Description
Intervention group: placebo oral tablet 2 tablets every 12 hours for seven nights
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Number2
Full name of responsible person
Farzaneh Jafarnejad
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodiy
Street address
University Avenue. Central Organization of Mashhad University of Medical Sciences
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin kiyani mesk
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Postal code
9137913199
Phone
+98 51 3852 8512
Fax
+98 51 3859 7313
Email
kianimm911@mums.ac.irmahin.kiani91@gmail.com
Web page address
http://nurse.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Jaafarnejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doctoora intersection. Ibn Sina Street
City
Mashhad
Postal code
9137913199
Phone
+98 51 3852 8512
Fax
+98 51 3859 7313
Email
jaafarnejadf@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin kiyani mesk
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
kianimm911@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)