Evaluation of the effects of topical application of micro emulsion prepared with black seed oil carrier of lipophilic active ingredients in the treatment of inflammatory disorders of Vulva vagina cavity

Evaluation of the effects of topical application of micro emulsion prepared with Black seed oil carrier of lipophilic active ingredients in the treatment of inflammatory disorders of vulva vaginal cavity.

Clinical trial with control group and two intervention groups 1 and 2, three blind strains, non-randomized, phase 2-3, on 99 patients, uses the Covariate Adaptive Randomization (CAR) method to distribute confounding variables to the study groups..

The research will perform in the hospitals clinic of Alborz University of Medical Sciences. After taking a history, the Obstetricians specialist examines the patients and according to the conditions for entering the research selects the desired samples in case of a definite diagnosis of rhinosinusitis. After introducing and obtaining consent according to the CAR method, patients are placed in one of the three intervention groups and patients are evaluated in several stages. The letters A and B are used on the drugs, so the analyzer, patients and physician are not aware of the treatment method.

Inclusion criteria include all patients with vulvovaginitis over the age of 15 and under 60 years old, not using special drugs during the last week, normal Pap smear test as well as exclusion criteria include patients with allergie to natural products and placement during pregnancy and lactation period.

Patients are intervened in three groups. In the control group, patients are treated with conventional oral tablets. In intervention group 1 Patients are treated with a topical solution containing micro emulsion made with flaxseed oil with conventional oral tablets. In intervention group 2 patients are treated with topical solution containing micro emulsion of black seed oil.

Inflammation of the mucosa of the vulva vaginal cavity

the researcher In order to blind the research for the patients and the treating physician, has prepared both samples of the drug and placebo in the same form so that they are not aware of the type of drug and placebo treatment. Sprays containing black seed oil micro emulsion and spray containing normal isotonic saline (placebo) in similar pumped bottles were marked with A and B marks, respectively. Also, oral antibiotic tablets and placebo tablets with A and B marks were placed in similar cans, respectively. The project clinical assistant then delivers the sprays and tablets, pre-marked A and B, based on the group that the patient has been categorized by sampling method. Also, the collected data with the same abbreviations A and B are delivered to the analyzer to be realized in the third strain of blinding.