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IRCT20180122038477N1 IRCT 2018-07-27 Ahvaz University of Medical Sciences oak Gall extract vaginal cream and metronidazole vaginal gel in treatment of bacterial vaginosis Comparison of the effect of oak Gall extract vaginal cream and metronidazole vaginal gel in treatment of bacterial vaginosis 2018-07-14 anticipated 84 Complete https://irct.ir/trial/29493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done a non-probabilistic manner.The method of assigning oak extract Cream (jaft) and metronidazole gel to patients is randomized and randomized blocks with block size 4 (using a random permutation table). A randomized list provide by statistician. In this study, oak extract Cream (jaft) and metronidazole gel will be placed in the closed envelopes according to the randomized list and different codes by the person outside the study then assigned to any patient that enter the study. oak extract Cream (jaft) and metronidazole gel are identical in appearance, packaging, color. The nature of the oak extract Cream (jaft) and metronidazole gel are apparent after the analysis of the result, Blinding description: In this study, Researcher and participants will be unaware of the type of treatment they receive (oak extract Cream (jaft) or metronidazole gel) and pharmacist will fill the tubes. For the purpose of blinding, oak extract Cream (jaft) and metronidazole gel tubes will be placed in closed envelopes according to the randomized list and different codes will be assigned to any patient that enters the study by a person outside the study. Oak extract Cream (jaft) or metronidazole gel tubes are identical in appearance, packaging and color. The nature of oak extract Cream (jaft) and metronidazole gel will be revealed after the analysis and patients will be reminded that their placement in each of the groups will be random. 3 Bacterial vaginosis. Intervention 1: Intervention group: oak extract (Jaft) 2.5% Vaginal cream, 5 mg per night for 5 nights. Intervention 2: Control group: metronidazole 75% gel, 5 mg every night for 5 nights. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Alham afzali
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3336 1984 afzali.e@ajums.ac.ir Ahvaz University of Medical Sciences scientific Elham Afzali
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8396 Afzali.e@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age of 15 to 45 years Being married Diagnosis of bacterial vaginosis with clinical symptoms and diagnostic tests 15 years 45 years Female Having a candida infection or trichomoniasis infection associated with bacterial vaginosis Pregnancy and Doubt to It Use of IUD Use antibiotic simultaneously or over the past two weeks Lactation Taking metronidazole for any reason at the same time N76.0 Acute vaginitis Treatment - Drugs Treatment - Drugs Intervention group: oak extract (Jaft) 2.5% Vaginal cream, 5 mg per night for 5 nights Control group: metronidazole 75% gel, 5 mg every night for 5 nights. Bacterial vaginosis cure. Timepoint: 4 to 7 days after treatment. Method of measurement: Based on the criteria of Amsell (Evaluation of vaginal discharge in terms of odor, color and presence of key cells with the emphasis on emphasis). Vaginal discharge. Timepoint: Before treatment and 4 to 7 days after treatment. Method of measurement: Observation. The acidity of vagina. Timepoint: Before treatment and 4 to 7 days after treatment. Method of measurement: PH strip. Whiff test. Timepoint: Before treatment and 4 to 7 days after treatment. Method of measurement: Potassium hydroxide solution 10%. Clue cells. Timepoint: Before treatment and 4 to 7 days after treatment. Method of measurement: Evaluation of clue cells on the wet lam. Ahvaz University of Medical Sciences Approved 2018-01-13 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences and Health Services Ahvaz Jundishapur University of Medical Sciences and Health Services,Golestan BLV,Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of) Approved 2018-01-13 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences and Health Services Ahvaz Jundishapur University of Medical Sciences and Health Services,Golestan BLV,Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of) Approved 2018-01-13 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences and Health Services Ahvaz Jundishapur University of Medical Sciences and Health Services,Golestan BLV,Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)