Comparison of the therapeutic effect of Honey and Nigella sativa (Dosin) vaginal cream and Clotrimazole vaginal cream in treatment Candida Vulvovaginitis

Evaluation of the therapeutic effect of honey and Nigella Sativa (Dosin) vaginal cream with Clotrimazole vaginal cream in treatment Candida Vulvovaginitis.

The study is conducted as a randomized triple-blind study .The sample size for comparison of two groups determine 84 women are infected with Candidal vulvovaginitis.

The study is conducted in Baharloo Hospital in the city of Tehran. Clotrimazole vaginal cream and and honey and Nigella Sativa (Dosin) vaginal cream are packaged similarly, and is marked ‘‘B’’ and ‘‘A’’. Samples, researcher, and statistical analysis are unaware of the content of cream. Therefore, the present study is conducted as a Triple-blind study

Exclusion criteria include :being at age of 18 to 49 years old, Not being pregnancy,Not being lactation, Not Having Allergy to Honey or Nigella Sativa or Clotrimazole,Not being period, Not using vaginal cream and vaginal doush and for last 48 hours before the study, Not using vaginal cream and vaginal doush and for last 48 hours before the study,Not Having recurrent Candida vaginitis (4 or more Candida vaginitis in a year), Not Having of history of curettage, Hysterosalpingography and uterine surgery in the last two weeks, No history of receiving blood or chemotherapy in a recent month,Having of signs and symptoms of Candida vaginitis, positive direct smear and culther of vaginal discharge, Exclusion criteria include:Not Agreeing to Participate in the Study, The use of antibiotics to treat non-vaginitis systemic infections during treatment, Participation at another trial, Pregnancy in the study time table

One group ( honey and Nigella Sativa (Dosin) vaginal cream ); Another group (Clotrimazole vaginal cream )

Outcome of culture of vaginal discharge; fungal symptoms

Describe how to randomize

the research units were divided into two groups of intervention and control, using four-dimensional permutation blocks. First, 6 possible blocks are listed (AABB, ABAB, BBAA, BABA, ABBA, BAAB) and each block is assigned a number from one to six. Then they are randomly assigned to the experimental and control groups using a random number table from one to six, followed by a block based on the number chosen. This will continue until the sample size is complete.

The patient is asked to fill out the letter of consent to participate in the study and simple randomly is assigned to two groups, case and control. Clotrimazole Vaginal cream and Honey and Nigella Sativa Vaginal cream are packaged similarly and is marked "A" and "B" by a pharmacist.Creams are applied each night as an applicator (5 g) inside the vagina for 7 nights. Samples, research group, and statistical analysis are unaware of the content of cream. the present study is conducted as a Triple-blind study.