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IRCT20210421051030N2 IRCT 2021-08-27 Alborz University of Medical Science Evaluation of the effects of solution made with black seed oil in the treatment of vulvovaginitis 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 2021-08-14 anticipated 99 Complete https://irct.ir/trial/56526 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: 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. 2-3 Vulvovaginitis. Intervention 1: Control group: the patients will treat by oral tablets (single dose of metronidazole 250 mg in bacterial vulvovaginitis and trichomoniasis and single dose of fluconazole 100 mg in candidate vulvovaginitis). They also receive a solution containing normal saline isotonic as a placebo made by BMS scientific and research group. Intervention 2: Intervention group 1: the patients will treat by a topical solution containing micro emulsion prepared with black seed oil made by BMS scientific and research group plus oral tablets (single dose of metronidazole 250 mg in bacterial vulvovaginitis and trichomoniasis and single dose of fluconazole 100 mg in candida vulvovaginitis). Intervention 3: Intervention group 2: the patients will treat by a topical solution containing black seed oil micro emulsion and placebo oral tablets made by BMS scientific and research group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Behnam Mokri Savojbolaghi
Iran university of medical sciences, Shahid hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6670 7140 bms1909@iran.ir Iran University of Medical Sciences scientific Behnam Mokri Savojbolaghi
Iran university of medical sciences, Shahid hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6670 7140 bms1909@iran.ir Iran University of Medical Sciences Iran (Islamic Republic of) All vulvovaginitis patients over 15 years of age and under 60 years of age Not used immunosuppressive and antibiotics drugs during the last week Normal Pap smear test 15 years 60 years Female Sensitivity to natural products Placement during pregnancy and lactation N76 Other inflammation of vagina and vulva Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: the patients will treat by oral tablets (single dose of metronidazole 250 mg in bacterial vulvovaginitis and trichomoniasis and single dose of fluconazole 100 mg in candidate vulvovaginitis). They also receive a solution containing normal saline isotonic as a placebo made by BMS scientific and research group. Intervention group 1: the patients will treat by a topical solution containing micro emulsion prepared with black seed oil made by BMS scientific and research group plus oral tablets (single dose of metronidazole 250 mg in bacterial vulvovaginitis and trichomoniasis and single dose of fluconazole 100 mg in candida vulvovaginitis). Intervention group 2: the patients will treat by a topical solution containing black seed oil micro emulsion and placebo oral tablets made by BMS scientific and research group. Inflammation of the mucosa of the vulva vaginal cavity. Timepoint: Before the intervention, During the intervention, after the intervention, one week after the intervention. Method of measurement: Visual Analogue Scale (Measure by Yes or No). Purulent vaginal discharge. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Vaginal itching. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Vaginal burning. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Malodor. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Painful intercourse. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Urine itching (Dysuria). Timepoint: Before the intervention, one week after the intervention. Method of measurement: Ù‹Questionnaire (Based on patient self-expression). Swelling of the mucosa. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Redness of the mucosa. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Mucosal lesions. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Mucosal ulcers. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. BMS science and research group Approved 2021-06-19 Ethics committee of Alborz University of Medical Sciences Deputy of Research and Technology, Saffarian Alley, 45 meters of Golshahr Karaj Alborz Iran (Islamic Republic of)