The present study aims to compare the effects of fluconazole(150mg) with vaginal(lacto flora fem) probiotic capsules with fluconazole(150mg) on vulvovaginal candidiasis.
Design
Randomized, parallel groups trial with blinding
Settings and conduct
The study is done in health care center in Matini Hospital in partnership with Diabetes center. patients and medical personnel are kept blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married non pregnant women aged 18-45 years old; absence of menstruation at the time of attendance; not using vaginal medications, antibiotics , immonosupressive drugs and exogenous hormones such as oral contraceptives since 2 weeks before starting the research; not having intercourse or using vaginal douche within the last 24 hours; diabetic patients; verification of vulvovaginal candidiasis resulted clinical symptoms and KOH positive samples and cultivation. Exclusion criteria: allergic reactions to fluconazole, Lacto Flora Fem; pregnancy during therapy; compulsion to use antibiotics or other anti fungal drugs.
Intervention groups
Intervention group: vaginal probiotic capsules(Lacto Flora Fem) are prescribed for 14 nights plus fluconazole (150mg) single dose orally.
Control group : vaginal placebo are prescribed for 14 nights plus fluconazole(150mg)single dose orally.
Main outcome variables
Vaginal candidiasis symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040071N1
Registration date:2018-08-16, 1397/05/25
Registration timing:prospective
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Parisa Mamivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3616 3625
Email address
Parisa.mamivand00@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2021-02-24, 1399/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the response to co- treatment of single dose fluconazole with vaginal lactobacillus in diabetic patients with vaginal candidiasis
Public title
Survey of response to co- treatment of single dose fluconazole with vaginal lactobacillus in diabetic patients with vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married women aged 18-45 years old
non pregnant
diabetic
no diagnosed medical disease such as auto immune diseases, by asking the patient
diagnosis of candidal vulvovaginitis by clinical symptoms, positive KOH test and cultivation
absence of menstruation at the time of attendance
not using vaginal medications, antibiotics , immonosupressive drugs and exogenous hormones such as oral contraceptives since 2 weeks before starting the research
not having intercourse or using vaginal douche within the last 24 hours
Exclusion criteria:
allergic reactions to fluconazole or lacto flora fem
pregnancy during therapy
use antibiotics or other anti fungal drugs
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria are randomized by using 4&6 blocks method. Randomization list is prepared before starting the intervention. Patients go under special treatment based on randomize allocation. Patient division conducts by the clerk of the clinic who is blinded to the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and therapist are blinded to the type of treatment due to similarity of the placebo and Lacto Flora Fem in shape.drug form and route of administration are similar. During assessment gynecologist will be blinded to the treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Scinces and Health Services
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.KAUMs.REC.139640
Health conditions studied
1
Description of health condition studied
Candidal Vulvovaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal candidiasis symptoms
Timepoint
1 month (30dayes ) after the use of probiotics or placebo
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights
Category
Treatment - Drugs
2
Description
Control group: : Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini hospital
Full name of responsible person
Zahra Vahedipoor
Street address
Amir kabir BLV , Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
87137/43444
Phone
+98 31 5554 1112
Email
mehdinazeri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidi
Street address
5th of Qotb –Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 1112
Email
parisa.mamivand00@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical Mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we express only clinical and laboratory outcomes
When the data will become available and for how long
Information will be published as article and final report
To whom data/document is available
Access limitation is not considered
Under which criteria data/document could be used
The final report and article will be available for other researchers
From where data/document is obtainable
Library of Kashan University of Medical Sciences
What processes are involved for a request to access data/document