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IRCT20191104045328N10 IRCT 2022-05-10 Arak University of Medical Sciences Comparison of the effect of oral metronidazole and vaginal probiotics on the microbial flora of the vagina and evaluation of treatment failure in women with bacterial vaginosis Comparison of the effect of oral metronidazole and vaginal probiotics on the vaginal microbial flora in women with bacterial vaginosis and evaluation of treatment failure 2022-05-22 anticipated 60 Complete https://irct.ir/trial/60519 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in. 2-3 Bacterial vaginosis. Intervention 1: Metronidazole group: Oral treatment with 500 mg metronidazole twice daily for 7 days. Intervention 2: Probiotic group: Probiotic vaginal capsules (lactobacillus acidophilus, lactobacillus plantarum, lactobacillus rhamnosos, lactobacillus gasseri) are taken once a day for 14 days. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2023/4/20 to 2026/4/20 for 3 years. To whom: University researchers Conditions: If there are any further questions Where to obtain: Dr. Nazila Najdi How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Nazila Najdi
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 najdinazila@gmail.com Arak University of Medical Sciences scientific Dr. Fatemeh Seidi
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 fatemehseidi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Women with a diagnosis of bacterial vaginosis Age between 18 and 45 years No pregnancy or HIV positive No history of known medical conditions such as epilepsy, diabetes, hypertension and heart and gastrointestinal problems Non-consumption of alcohol and anticoagulants such as coumadin (warfarin), immunosuppressants, vaginal medications, having an IUD 18 years 45 years Female Dissatisfaction with continued cooperation Having serious drug side effects Do not take nutritional supplements Existence of other non-bacterial infections of the vagina Taking antibiotics N76.0 Acute vaginitis Treatment - Drugs Treatment - Drugs Metronidazole group: Oral treatment with 500 mg metronidazole twice daily for 7 days. Probiotic group: Probiotic vaginal capsules (lactobacillus acidophilus, lactobacillus plantarum, lactobacillus rhamnosos, lactobacillus gasseri) are taken once a day for 14 days. Amsel positive criteria. Timepoint: After the intervention. Method of measurement: Clinical examination and swabs biopsy of the vaginal wall. Nugent score. Timepoint: After the intervention. Method of measurement: Gram stain scoring system for vaginal swabs. The pH of vaginal discharge. Timepoint: Before and after the intervention. Method of measurement: PH meter tape with a range of 1/6 - 6/3 made by Machery – Nagel, Düren, Germany. Existence of homogeneous dilute white-gray discharge. Timepoint: Before and after the intervention. Method of measurement: Clinical examination and swabs biopsy of the vaginal wall. Amine test. Timepoint: Before and after the intervention. Method of measurement: Production of amine odor by adding 10% KOH solution to vaginal discharge. The presence of Clue cells in the vaginal discharge slide. Timepoint: Before and after the intervention. Method of measurement: Preparation of microscopic slide sample from swap vaginal discharge. Arak University of Medical Sciences Approved 2021-07-18 Ethics Committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran Arak Markazi Iran (Islamic Republic of)