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

The purpose of this study is to compare the effect of poulk vaginal gel and metronidazole gel in the treatment of bacterial vaginosis.

In this double-blind study there are 112 women with bacterial vaginosis who have the criteria for entering the study. They are randomly divided into intervention and control groups.

This study was carried out in clinics affiliated with Lorestan University of Medical Sciences in women with diagnosis of trichomoniasis, based on patient complaints, clinical observations and wet and colored microscopic tests. Clinical observations and wet microscopic and staining tests are reviewed within 7 days of treatment.

Entering criteria into the study were as fallowing : Tending to cooperate ; positive Gram stain for BV ; Positive Whiff Test ; Positive clinical observations ; Existing criteria are fallowing entries : 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 ;Multi partner ; Stricken to specific diseases like liver diseases ,kidney diseases and central chords system diseases ,blood dyscrasi ,diabetes ,impair of safety system ; President of allergy in using metronidazol tablet

Intervention group: Vaginal gel of Poulk 5%, 50 mgr, made by Ahvaz School of Pharmacy 5 mg every night applicator vaginally for 7 nights. Control group: Metronidazole vaginal gel 0.75%, 50 mg, 5 mg every night with applicator vaginally for 7 nights.

Bactrial Vaginosis ; Sexual function ; Sexual satisfaction

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.

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.