Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
NCT ID: NCT04558697
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2019-03-21
2019-09-30
Brief Summary
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This was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. Patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. Three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Shepherd's Purse extractum oleosum vagitories
Vagitories containing Calendulae extractum oleosum 5,5% (w/w), Bursae pastoris extractum oleosum 5,5% (w/w), Matricariae extractum oleosum 5,5% (w/w), Hyperici extractum oleosum 5,5% (w/w) and Millefolii extractum oleosum 5,5% (w/w) as active component
Shepherd's Purse extractum oleosum vagitories
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Tea tree oil vagitories
Vagitories containing tea tree oil, 200 mg per each vagitorie as active component
Tea tree oil vagitories
Tea tree oil vagitories will be administered once daily for 5 days
Hyperici extractum oleosum vagitories
Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component
Hyperici extractum oleosum vagitories
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Vagitories - Probiotic
Commercially available vagitories with probiotic
Vagitories - Probiotic
Vagitories - Probiotic will be administered once daily for 5 days
Interventions
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Shepherd's Purse extractum oleosum vagitories
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Tea tree oil vagitories
Tea tree oil vagitories will be administered once daily for 5 days
Hyperici extractum oleosum vagitories
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Vagitories - Probiotic
Vagitories - Probiotic will be administered once daily for 5 days
Eligibility Criteria
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Inclusion Criteria
* diagnosis of non-specific vaginal inflammation by medical examination.
Exclusion Criteria
* treatment with antibiotic therapy according to official protocols and guidelines
* allergies to one of the plant species included in the vaginal test,
* diabetes mellitus,
* pregnancy,
* lactation,
* immunodeficiency disorder,
* severe chronic illness,
* previous radiotherapy, chemotherapy and biological therapy
18 Years
FEMALE
Yes
Sponsors
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Institution for Health Protection of Women and Motherhood
UNKNOWN
University of Tuzla
UNKNOWN
University of Sarajevo
OTHER
Responsible Party
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Kemal Durić, PhD
Kemal Duric PhD, Associate Professor
Principal Investigators
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Fahir Becic, PhD
Role: STUDY_CHAIR
Universiyt of Sarajevo Faculty of Pharmacy
Locations
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Kemal Duric
Sarajevo, Canton Sarajevo, Bosnia and Herzegovina
Countries
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Other Identifiers
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03/7-1053/19
Identifier Type: -
Identifier Source: org_study_id
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