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Study aim
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Evaluation of the effectiveness of frankincense vaginal gel with overnight use for one week in the treatment of clinical and laboratory symptoms in culture and smear of candidal vaginal infection in patients
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Design
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Three-way blind clinical trial, with control group, randomized, phase 3 on two groups of 90 patients. A table of random numbers and 4 blocks will use for randomization.
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Settings and conduct
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Patients treated with symptoms and diagnosis of candidal vaginitis referred to the clinic will treat with frankincense gel, frankincense gel for one week at night.
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Participants/Inclusion and exclusion criteria
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Criteria for admission to the study: married women aged 20 to 55 who referred to hospitalization centers despite symptoms of vaginal candidiasis, including burning, itching, pain and dys paronis,
Criteria for non-entry: antibiotic use in the last two weeks, pregnancy, lactation, mental retardation, addiction, systemic corticosteroid or OCP use, diabetes, anatomical problems of the vulva and vagina, concomitant genital infection, vaginal bleeding of origin Unknown
Criteria for withdrawal : no improvement in clinical symptoms after 72 hours from the start of the drug, pregnancy, patient dissatisfaction with continuing treatment, drug side effects, failure to take 3 doses (3 nights)
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Intervention groups
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An applicator of the drug will administer vaginally for seven nights. The form of drug side effects is given to the patient and the necessary explanations will give. If the test results are negative, the patient will be excluded from the study.
After 48 hours from the end of the medication (9 days after the first visit), a face-to-face visit and re-filling of the questionnaires is performed.
During the study period, appropriate action will be taken if any of the exit criteria are met.
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Main outcome variables
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pain, Burning, Itching, Dispareunia, vaginal discharge