َA comparative study of the therapeutic effect of the propolis vaginal cream and metronidazol vaginal gel on bacterial vaginosis in reproductive aged women
This study will carry out to compare the effect of Propolis vaginal cream with metronidazol vaginal gel on the treatment results of bacterial vaginitis . This clinical trial will conduct on 100 reproductive aged women for a period of 10 months .They will divide into two groups of 50 subjects(Metronidazol and Propolis) by randomized allocation method. all the patients will apply the drug once a day for 10 days only. The results will compare after 10 days of therapy with respect to nugent score changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408202325N2
Registration date:2014-09-09, 1393/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Mahsa Sadat Mousavi
Name of organization / entity
Khorasgan (Isfahan) Branch, Islamic Azad University, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3272 4301
Email address
moosavimh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Islamic Azad University of Isfahan ( Khorasgan Branch)
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
َA comparative study of the therapeutic effect of the propolis vaginal cream and metronidazol vaginal gel on bacterial vaginosis in reproductive aged women
Public title
َA comparative study of the therapeutic effect of the propolis vaginal cream and metronidazol vaginal gel on bacterial vaginosis in reproductive aged women referring to gynecology clinics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to participate; reproductive age (between 18 years ; premenopause age. Exclusion Criteria: pregnancy; breast feeding; using hormonal or immunosuppressive drugs; having sexually transmitted and autoimmune diseases or allergy; using antibiotics or vaginal drugs during two weeks prior to the study; using other supportive treatments like vaginal douche at the time of drug application.
Age
From 18 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan,HezarJarib St.Vice chancellor for Research,Isfahan University of Medical Sciences
City
Isfahan
Postal code
81745319
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
492013
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Therapeutic effect of bacterial vaginosis
Timepoint
10 days
Method of measurement
Gram Stain
Secondary outcomes
1
Description
Vaginal Itching
Timepoint
After 10 days
Method of measurement
Questionnair
Intervention groups
1
Description
All the patients have the Amsels criteria and positive gram stain. They will divide into two groups of 50 subjects(Metronidazol vaginal gel and Propolis vaginal cream ) by randomized allocation method.In intervention group patients will use one aplicator of propolis vaginal cream of 7.5 % once a day for 10 days only.
Category
Treatment - Drugs
2
Description
In control group patients will apply the metronidazol vaginal gel once a day for 10 days only.The results will compare after 10 days of therapy with respect to nugent score changes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic of Zeinabieh hospital
Full name of responsible person
Street address
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan Branch)
Full name of responsible person
Mahsa Sadat Mousavi
Street address
Isfahan,Jey St
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Isfahan(Khorasgan Branch)
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
Islamic Azad University of Isfahan(Khorasgan Branch)
Full name of responsible person
Mahsa Sadat Mousavi
Position
Instructor
Other areas of specialty/work
Street address
Isfahan,Jey St
City
Isfahan
Postal code
Phone
+98 315354001
Fax
Email
m.mousavi@khuisf.ac.ir
Web page address
www.khuisf.ac.ir/prof/mosavi
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan Branch)
Full name of responsible person
Mahsa Sadat Mousavi
Position
Instructor
Other areas of specialty/work
Street address
Isfahan,Jey St
City
Isfahan
Postal code
Phone
+98 31 3535 4058
Fax
Email
m.mousavi@khuisf.ac.ir
Web page address
www.khuisf.ac.ir/prof/mosavi
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan Branch)
Full name of responsible person
Mahsa Sadat Mousavi
Position
Instructor
Other areas of specialty/work
Street address
Isfahan,Jey St
City
Isfahan
Postal code
Phone
+98 31 3535 4058
Fax
Email
m.mousavi@khuisf.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)