A Phase 4 interventional study of Shepherd's Purse extractum oleosum vagitories and Tea tree oil vagitories in Non Specific Vaginitis, sponsored by University of Sarajevo. Completed at 1 site in Bosnia and Herzegovina. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by University of Sarajevo · Phase 4, Interventional, and Treatment
There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis.
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 210 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →University of Sarajevo is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Drug: Shepherd's Purse extractum oleosum vagitories
Vagitories containing tea tree oil, 200 mg per each vagitorie as active component
Drug: Tea tree oil vagitories
Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component
Drug: Hyperici extractum oleosum vagitories
Commercially available vagitories with probiotic
Drug: Vagitories - Probiotic
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Tea tree oil vagitories will be administered once daily for 5 days
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Vagitories - Probiotic will be administered once daily for 5 days
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
The clinical symptoms and signs, including redness, hyper-secretion, local edema, pain and annealing were diagnosed at the baseline and 5 days after the beginning of the treatment. Gynecologist determined only the presence or absence of the above mentioned symptoms.
Time frame: 1 day after treatment completion
Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination
Subjective symptoms including vaginal secretion, itching and dryness of the vaginal mucous were diagnosed at the baseline and 5 days after beginning of the treatment. During anamnesis gynecologist determined the presence or absence of the above mentioned symptoms.
Time frame: 1 day after treatment completion
Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner
At the baseline, the patents completed a questionnaire that included questions regarding their age, life habits (permanent relationship, smoker, use of alcohol,number of births, abortion number) and sexual behavior (number of partners, years of first sexual intercourse, contraceptive use, previous presence of sexually transmitted diseases). The incidence of vaginitis correlated to above mentioned demographic data will be assessed by questioner
Time frame: Through study completion, an average of 3 months
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Sarajevo