ThisTriple-blind clinical trial was held on 61 women, referred to gynecologic clinics Tamin ejtemaie of Mashhad in 2015. Data collecting tools included: the Questionnaire concerning demographic profile, check list of amsel criteria for the first, second and third referral, and pH indicator paper, Scales and weights.Patients were divided randomly in these two groups:" honey vagina gel and Metronidazole vaginal gel.Amsel criteria and patients complaints was recorded befor and 7 and 30 days after the completion of treatment. Treatment success was considered as absence of 4 Amsel criteria or presence of one of the Amsel criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012826244N1
Registration date:2016-07-19, 1395/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-19, 1395/04/29
Registrant information
Name
Negar Saki
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3759 3477
Email address
sakin911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison effects of honey vaginal gel and vaginal gel metronidazole on treatment of recurrent bacterial vaginosis
Public title
The comparison of honey vaginal gel with metronidazole vaginal gel on treatment of recurrent bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: proven recurrent bacterial vaginosis based on the history (of 3 or more than 3 times recurrence of symptoms and the clinical Amsel criteria; women 18-49 years old; married; single spouse; the absence of pregnancy and lactation; signed informed consent to participate in the study; not taking any vaginal medications in last 48 hours; not taking any antibiotics during the last 3 weeks; lack of vaginal intercourse or shower in the last 24 hours; no smoking; no alcohol consumption ; not taking any anticoagulants such as Coumadin and disulfiram; there is not any known medical condition like diabetes; blood Dyskrazy; thyroid disease and liver disease history; do not use IUD.
Exclusion criteria: patient's request ; the medication is not used for more than once; no condom use during the course of treatment; Menstruation .
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Doctora intersection, Ibn Sina Street, Mashhad
City
Mashhad
Postal code
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
IR.MUMS.REC.1394.489
Health conditions studied
1
Description of health condition studied
Recurrent bacterial vaginosis
ICD-10 code
N76.7
ICD-10 code description
Other specified inflammation of vagina and vulva
Primary outcomes
1
Description
Recurrent bacterial vaginosis
Timepoint
Before treatment and after treatment
Method of measurement
Observation
Secondary outcomes
1
Description
Recurrent bacterial vaginosis treatment
Timepoint
7 and 30 days after treatment
Method of measurement
observation
Intervention groups
1
Description
Intervention1: Metronidazole vaginal gel in this study, 750 mg (0.75 percent) to 0.75 grams per 100 grams of metronidazole to using an applicator is recommended every night (about 5cc) before bed for 7 night
Category
Treatment - Drugs
2
Description
Intervention 2: produced honey gel with the Iranian standards and license-mahram 30/10233.represent every night an applicator (about 5cc) applied at night before bed for seven night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tamin Ejtemaie Gynecology Clinics of Mashhad
Full name of responsible person
Negar Saki
Street address
Kohsangi Street, Mashhad
City
Mashhsd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central Organization of Mashhad University of Medical Sciences, University Avenu, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research 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
Negar Saki
Position
Masters Student
Other areas of specialty/work
Street address
Doktora intersection, Ibn Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sakin911@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doktora intersection, Ibn Sina Street, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
tafazolim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negar Saki
Position
Masters Student
Other areas of specialty/work
Street address
Doktora Intersection, Ibn Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
negar.saki@gmail .com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)