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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210421051030N2

Enrollment

Registered

2021-08-27

Start date

2021-08-14

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginitis. Other inflammation of vagina and vulva

Interventions

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 cand

Eligibility

Sex/Gender

Female

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Sensitivity to natural products Placement during pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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: ?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.	—

Measure

Time frame

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: ?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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnam Mokri Savojbolaghi

Iran University of Medical Sciences

bms1909@iran.ir+98 21 6670 7140

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026