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IRCT138711201548N3 IRCT 2012-05-07 Deputy for Research of Shiraz University of Medical Sciences A comparison between the effect of vaginal probiotic capsules and the oral tablet of Metronidazol on combined bacterial and trichomonial vaginitis. A comparison between the effect of vaginal probiotic capsules and the oral tablet of Metronidazol on combined bacterial and trichomonial vaginitis in selected gynecology clinics of Shiraz University of Medical Science, 1390 2011-12-22 anticipated 100 Complete https://irct.ir/trial/834 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Trichomonas vaginitis. Condition 2: Trichomonas vaginitis. Intervention 1: vaginal probiotic capsule,once daily until 10 day. Intervention 2: Control group: standard treatment with oral metronidazole 250 mg tablet every 12 hours, 2 to 7 days.
public Khadijeh Abdali
Namazi Sq.
Shiraz Iran (Islamic Republic of) +98 71164742528 abdalikh@sums.ac.ir Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz scientific Dr Sedigheh Amoei
School of Medicine, Imam Hossein Square, Zand Avenue
Shiraz Iran (Islamic Republic of) +98 71 1230 5410 sedighehamooee@gmail.com School of Medicine Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria of the study: Non-pregnant, non-lactating, and non-smoker women who aged between 18 and 55, being married, being willing to participate in the research, being in the follicular phase of the menstrual cycle, having signs of trichomoniasis on physical examination, having signs of bacterial vaginosis on physical examination, not having abnormal vaginal bleeding at the time of sampling, not having vaginal intercourse and douching during 48 hours prior to the study, not taking vaginal medication, such as creams, suppositories, and vaginal disinfectants in 48 hours before the study, not taking medication for treatment during the last 3 months, not suffering from specific diseases, such as liver, heart, and kidney diseases, diabetes, central nervous system diseases, blood discrasia, immune system defects, and known sexually transmitted diseases, not having used broad-spectrum antibiotics, anti-prostaglandins, hormone and immunosuppressive drugs, alcohol, and anticoagulation in recent months, no history of sensitivity to metronidazole tablets, not having vulvovaginitis four or more times during the year, and not having multiple sexual partners. Exclusion criteria of the study: Having allergy to the elements of the probiotic products which were used in the study, being considered unhealthy based on the clinical diagnosis, while having negative test results, and having allergy to the medication compounds used in the study. 18 years 55 years Female A59 A59 Urogenital trichomoniasis Urogenital trichomoniasis Treatment - Drugs Treatment - Drugs vaginal probiotic capsule,once daily until 10 day Control group: standard treatment with oral metronidazole 250 mg tablet every 12 hours, 2 to 7 days. Gram stain,wet smear and clinical signs. Timepoint: Before intervention,1week and 10 days after intervention. Method of measurement: questionnaire. Side effects. Timepoint: 7-10 days after intervention. Method of measurement: questionnaire. Deputy for Research of Shiraz University of Medical Sciences Approved 2011-12-01 Medical Research Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences shiraz Iran (Islamic Republic of)