Evaluation of the Effect of Vaginal Cream of Aqueous Extract from Aerial Part Scrophularia Striata on Bacterial Vaginitis in Married Women with Aged 18 to 45 Years: a Triple Blind, Randomized, Controlled Clinical Trial

Investigating the effect of vaginal cream of aqueous extract of the scrophularia striata plant on bactrial vaginosis

Clinical trial with control group with parallel groups three_way blind randomized phase 3 on 120 patients. A tablet of random numbers is used for randomization.

This study will be conducted in the form of a three blind controlled clinical trial with the aim of investigating the effect of the vaginal cream of the aqueous extract of the scrofularia striata plant on bacterial vaginitis infections during 1402. they refer to the women department of Shahid Rahimi Hospital in Khorramabad city for treatment and meet the conditions for entering the study based on the mentioned criteria.

Inclusion criteria: Women in the age range of 18 to 45 years, being married, having at least 3 of the 4 amsel criteria, having informed consent, BMI less than 30 Exclusion criteria: Inability of the patient to complete the treatment protocol, presence if other vaginitis along with bacterial vaginitis, the patients lack of consent to continue participating in the study, pregnancy, abnormal vaginal bleeding, other systemic diseases, history of smoking drugs alcohol, use of cryothetapy during the six weeks before the study, history of frequent infections (4 or more than 4 times a year), history of allergy to medicinal herbs and metronidazol, using antibiotics in the last two weeks, using vaginal creams suppositories or shower in the last 48 hours

Intervention group: Metronidazol gel plus vaginal cream containing Scrophularia Striata plant extract control group: Metronidazol gel plus placebo vaginal cream

Examination of clinical symptoms of vaginal burning, vaginal itching, pain during intercourse, examination of Amsels clinical criteria

The samples will be selected consecutively and easily from the eligible people of the studied community and will be assigned to the fore studied groups using the random block method. This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups during randomization, and at certain points the number of participants is each group is equal. For this method, the size of each block must be determined first (example block of four). Then write the list of blocks and assign numbers to them (AABB(1)-ABAB(2)-ABBA(3)-BBAA(4)-BABA(5)-BAAB(6)) Then choose random number between 1 and 6 (for example, 1,4,5 and...) and finally specifying the treatment allocation list based on the previous random numbers(AABB-BBAA-BABA...).

The sample will be studied in a three-way blind way, so that the patient, the researcher, and the statistical analyst will not know which th ey are in arm. In this study, each group of drugs will be specified as boxes A and B will be provided to the researcher, and patient will randomly choose one of the boxes after visiting.

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