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IRCT20201201049560N1 IRCT 2021-02-15 Ahvaz University of Medical Sciences The comparative of Poulk vaginal gel and metronidazole vaginal gel effect on treatment of bacterial vaginosis The comparative of Poulk vaginal gel and metronidazole vaginal gel effect on treatment of bacterial vaginosis in Vaginosis patients : A Double Blind Randomized Clinical Trial 2021-05-12 anticipated 112 Complete https://irct.ir/trial/52708 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients will be assigned to two groups of Poulk gel (50 g, 5%) and Metranidazole gel (50g 75%) and written consent will be obtained from patients to participate in this study. In the first group, 75% of metranidazole gel will be given daily in an intravaginal applicator daily for 7 days and in second group, 5% of poulk gel will be given daily in applicator for 7 days. Patients will be advised to stay in the supine position for at least 30 minutes after taking the drug. Patients will also be given the Larson sexual satisfaction questionnaire and FSFI sexual function questionnaire, Randomization description: The allocation of individuals in the groups will be done in a random block with 19 blocks of 6 by allocation 1:1 in the two groups.In this way, the letters A and B will be assigned to each group, and randomized list provide by statistician. In this study, almost all possible cases of 19 blocks of 6 and assigning numbers to each of them are prepared randomly by a statistician using the WWW.Randomizer.org site. Poulk vaginl gel 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. Poulk vaginal gel and metronidazole gel are identical in appearance, packaging, color, Blinding description: In this study, Researcher and participants will be unaware of the type of treatment they receive Poulk vaginal gel or metronidazole gel and pharmacist will fill the tubes. For the purpose of blinding, Poulk vaginal gel 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. Poulk vaginal gel or metronidazole gel tubes are identical in appearance, packaging and color. The patients will be reminded that their placement in each of the groups will be random. 2-3 Bacterial Vaginosis. Intervention 1: 5% vaginal gel, 50 g, 7 days, 1 applicator 5 g every night while sleeping inside the vagina. Extraction(Extraction of plant leaves using soaking method and using 80% aqueous solutions) and making of gel is done in school of pharmacy in Ahvaz Medical Science . Intervention 2: Control group: metronidazole vaginal gel(an applicator 75%) once a day for 7 days. Metranidazole gel made by Behsan Daroo comopany, Which is placed in tubes similar to poulk vaginal gel in school of pharmacy in Ahvaz Medical Science. 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 There is not more information.
public Mina Iravani
Ahvaz Jundishapur University of Medical Sciences,Golestan Blvd, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8331 minairavani2004@yahoo.com Ahvaz University of Medical Sciences scientific Mina iravani
Ahvaz,Golestan Blvd, University of Medical Sciences, Ahvaz,
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8331 minairavani@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) willingness to cooperate positive Whiff test signs of bacterial vaginosis in examination Positive cluecell 18 years no limit Female Multi partner Stricken to specific diseases like liver diseases ,kidney diseases and central chords system diseases ,blood dyscrasi ,diabetes ,impair of safety system Having abnormal uterus bleeding Frequently vulvovaginits pregnancy Mensturation Lactating Use of vaginal douches frequently, consuming remedy for treatment in 3 recent months Consumig alcohol and anti coagulation remedies and recent consuming anti-parasite remedy, anti-biotic, weakening remedy of safety system and vaginalis remedy President of allergy in using metronidazol tablet consuming remedy for treatment in 3 recent months N76.7 Other specified inflammation of vagina and vulva Treatment - Drugs Treatment - Drugs 5% vaginal gel, 50 g, 7 days, 1 applicator 5 g every night while sleeping inside the vagina. Extraction(Extraction of plant leaves using soaking method and using 80% aqueous solutions) and making of gel is done in school of pharmacy in Ahvaz Medical Science . Control group: metronidazole vaginal gel(an applicator 75%) once a day for 7 days. Metranidazole gel made by Behsan Daroo comopany, Which is placed in tubes similar to poulk vaginal gel in school of pharmacy in Ahvaz Medical Science. Bacterial Vaginosis. Timepoint: Before treatment and 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) and Nugent. Vaginal discharge. Timepoint: 14-28 days after treatment. Method of measurement: Observation. The acidity of vagina. Timepoint: 14-28 days after treatment. Method of measurement: PH strip. Whiff test. Timepoint: 14-28 days after treatment. Method of measurement: Potassium hydroxide solution 10%. Clue cells. Timepoint: 14-28 days after treatment. Method of measurement: Evaluation of clue cells on the wet lam. Sexual Fanction score. Timepoint: Before and 14 days after treatment. Method of measurement: Rosen Sexual Function Questionnaire. Sexual Satisfaction score. Timepoint: Before and 14 days after treatment. Method of measurement: Larson Sexual Satisfaction Questionnaire. Ahvaz University of Medical Sciences Approved 2021-01-22 Ethics committee of Ahvaz University of Medical Sciences Ahvaz, Expressway, Golestan University of Medical Sciences, Ahvaz, Ahvaz Khouzestan Iran (Islamic Republic of)