]>
IRCT20180612040071N2 IRCT 2020-01-03 Kashan University of Medical Sciences Effect of probiotic on treatment of bacterial vaginitis and preservation of vaginal bacterial flora in patients treated with metronidazole Effect of probiotic on treatment of bacterial vaginitis and preservation of vaginal bacterial flora in patients treated with metronidazole 2019-11-26 anticipated 128 Complete https://irct.ir/trial/43195 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 bacterial vaginosis. Intervention 1: Intervention group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with probiotic suppository every 3 days for 3 weeks. Intervention 2: Control group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with placebo suppository every 3 days for 3 weeks. 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, 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) Women with bacterial vaginitis according to the Amsel criteria married 18-48 years old 18 years 48 years Female People with immunodeficiency disease and HIV People with genital and urinary tract infections Antibiotic users within two weeks prior to inclusion Patients with candidiasis vaginitis Menopause Pregnant women or during lactation Patients who do not allow pelvic examination N70-N77 Inflammatory diseases of female pelvic organs Treatment - Drugs Placebo Intervention group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with probiotic suppository every 3 days for 3 weeks. Control group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with placebo suppository every 3 days for 3 weeks. Bacterial vaginitis symptoms. Timepoint: 1 month (30dayes ) after the use of probiotics or placebo. Method of measurement: questionnaire. Kashan University of Medical Sciences Approved 2019-08-26 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)