Comparison of the effect of oak Gall extract vaginal cream and metronidazole vaginal gel in treatment of bacterial vaginosis

The purpose of this study is to compare the effect of vaginal cream extract of oak(jaft) and vaginal metronidazole gel in the treatment of bacterial vaginosis.

In this double-blind study there are 84 women with bacterial vaginosis who have the criteria for entering the study. They are randomly divided into intervention and control groups.

This study is a double-blind, randomized controlled clinical trial that will be carried out in women with bacterial vaginosis referring to the women's clinic of Imam Khomeini Hospital, Amiralmomenin Women's Clinic, and Ahvaz Medical Center No. 1 Hospital. Volunteers are randomly assigned to the intervention and control groups using the block randomization method (block of size 4). The researcher and the volunteer will be completely unaware of the content of the vaginal medicine tubes, and pharmaceutical tubes will be filled up by the pharmacist.

Inclusion criteria: at the age of 15-45 years old; being married; diagnosis of bacterial vaginosis with clinical signs and diagnostic tests. Exclusion criteria: Having Candida infection or Trichomoniasis infection with bacterial vaginosis; being pregnant or suspicion of pregnancy; Using IUD; Lactation; Using antibiotics concurrently or during the last two weeks; Using metronidazole for any reason

Intervention group: oak extract vaginal cream. Control group: metronidazole vaginal gel

Cure of bacterial vaginosis; vaginosis clinical and laboratory signs alleviation; reduction of target infectious factors including pathogenic bacteria.

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.

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.