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IRCT20090701002114N7 IRCT 2020-11-16 Khoram-Abad University of Medical Sciences The effect of lactofem on the vaginosis The effect of lactofem capsule on the treatment of bacterial vaginosis in pregnant women 2020-11-14 anticipated 72 Complete https://irct.ir/trial/52002 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be randomly assigned to the study after visiting the gynecology clinic. Randomization will be in the form of blocking in such a way that the method of replacement blocks is used within each floor. The blocks will be binary, consisting of AB and BA. The randomization tool will be a table of random numbers, that using the sequence AB for numbers zero through 4 in the random number table and the sequence BA for 5 to 9.It should be noted that the letter A means the intervention group and the letter B means the control group, Blinding description: This study will be a three-way blind and the patient, researcher and statistical analyst of the patients' group therapy have no information and the decoder is outside the research team. The drug under study (lactofem) and placebo in a completely similar shape and appearance, each of which is 30 in the same bottle instead of the drug will be provided to the subjects based on random allocation. It should be noted that the drug content of each The bottles are code-tagged on the bottles by the pharmacist consultant and the research team is not aware of their interpretation. 3 Bacterial vaginosis infection. Intervention 1: Intervention group: pregnant women who have a bacterial vaginosis infection according to a doctor's examination will be treated with Lactofem oral capsules and will take one capsule daily for one month. After a month, they will be examined by a doctor. Intervention 2: Control group: In this group, instead of lactofem capsule, a placebo capsule with a similar shape and appearance will be used. Placebo will be used daily for a month. After a month, they will be examined by a doctor. Yes - There is a plan to make this available What will be shared: It is possible to share all the data while maintaining the principle of not mentioning the names of individuals When: One year after the publication of the related article To whom: Researchers of university centers Conditions: For additional research and production of probiotic therapeutic compounds, the data of the present study can be used after obtaining permission and approval from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences Where to obtain: Refer to the project manager, Dr. Fatemeh Yari, with email address yari1672@yahoo.com, and contact number 09163613621 How to obtain: After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager. Can access documentation. Comments:
public Fatemeh Yari
Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand
Khorramabad Iran (Islamic Republic of) 381351698 +98 66 3312 0133 yari.f@lums.ac.ir Khoram-Abad University of Medical Sciences scientific Fatemeh Yari
Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand
Khorramabad Iran (Islamic Republic of) 381351698 +98 66 3312 0133 yari.f@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Gestational age over 12 weeks Bacterial vaginosis infection 18 years 45 years Female Concomitant infection with Trichomonas or candidiasis Gestational diabetes urinary tract infection Rupture of the amniotic sac Immune system defects Inflammatory bowel disease Treatment - Drugs Placebo Intervention group: pregnant women who have a bacterial vaginosis infection according to a doctor's examination will be treated with Lactofem oral capsules and will take one capsule daily for one month. After a month, they will be examined by a doctor. Control group: In this group, instead of lactofem capsule, a placebo capsule with a similar shape and appearance will be used. Placebo will be used daily for a month. After a month, they will be examined by a doctor. Bacterial vaginosis. Timepoint: Evaluation of vaginal infection at the beginning of the study and one month after taking Lactofem capsules. Method of measurement: Vaginal examination by physician. Khoram-Abad University of Medical Sciences Approved 2019-03-05 Ethics committe of Lorestan University of Medical Sciences Office of Research Ethics Committee, Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, University Campus Complex, km 3 of Khorramabad Boroujerd Road, Khorramabad Khorramabad Lorestan Iran (Islamic Republic of)