Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation

Study Overview
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Brief Summary
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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.

Official Title
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Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation

Conditions
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Non Specific Vaginitis

Intervention / Treatment
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* Drug: Shepherd's Purse extractum oleosum vagitories
* Drug: Tea tree oil vagitories
* Drug: Hyperici extractum oleosum vagitories
* Drug: Vagitories - Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult women who already had sexual intercourse diagnosis of non-specific vaginal inflammation by medical examination. Exclusion Criteria: microbiologically confirmed bacterial vaginosis, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shepherd's Purse extractum oleosum vagitories<br>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<br>* Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days<br>|
| Experimental: Tea tree oil vagitories<br>Vagitories containing tea tree oil, 200 mg per each vagitorie as active component | Drug: Tea tree oil vagitories<br>* Tea tree oil vagitories will be administered once daily for 5 days<br>|
| Experimental: Hyperici extractum oleosum vagitories<br>Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component | Drug: Hyperici extractum oleosum vagitories<br>* Hyperici extractum oleosum vagitories will be administered once daily for 5 days<br>|
| Active Comparator: Vagitories - Probiotic<br>Commercially available vagitories with probiotic | Drug: Vagitories - Probiotic<br>* Vagitories - Probiotic will be administered once daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Through study completion, an average of 3 months |