]>
IRCT20180612040071N1 IRCT 2018-08-16 Kashan University of Medical Sciences Survey of response to co- treatment of single dose fluconazole with vaginal lactobacillus in diabetic patients with vaginal candidiasis Assessing the response to co- treatment of single dose fluconazole with vaginal lactobacillus in diabetic patients with vaginal candidiasis 2019-09-06 anticipated 130 Complete https://irct.ir/trial/31998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Candidal Vulvovaginitis. Intervention 1: intervention group: Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights. Intervention 2: Control group: : Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights. Yes - There is a plan to make this available What will be shared: we express only clinical and laboratory outcomes When: Information will be published as article and final report To whom: Access limitation is not considered Conditions: The final report and article will be available for other researchers Where to obtain: Library of Kashan University of Medical Sciences How to obtain: Direct referral to the library Comments:
public Mehdi Nazeri
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 nazeri_me@kaums.ac.ir Kashan University of Medical Sciences scientific Mehdi Nazeri
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 nazeri_me@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Female allergic reactions to fluconazole or lacto flora fem pregnancy during therapy use antibiotics or other anti fungal drugs B37.3 Candidiasis of vulva and vagina Treatment - Drugs Placebo intervention group: Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights Control group: : Oral single dose Fluconazol (150mg) treatment with vaginal Lacto Flora Fem for 14 nights Vaginal candidiasis symptoms. Timepoint: 1 month (30dayes ) after the use of probiotics or placebo. Method of measurement: questionnaire. Kashan University of Medical Sciences Approved 2017-05-31 Ethics committee of Kashan University of Medical Scinces and Health Services 5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN kashan Isfehan Iran (Islamic Republic of)