Non Specific Vaginitis
Conditions
Brief summary
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.
Interventions
DRUGShepherd's Purse extractum oleosum vagitories
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
DRUGTea tree oil vagitories
Tea tree oil vagitories will be administered once daily for 5 days
DRUGHyperici extractum oleosum vagitories
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
DRUGVagitories - Probiotic
Vagitories - Probiotic will be administered once daily for 5 days
Sponsors
Institution for Health Protection of Women and Motherhood
University of Tuzla
University of Sarajevo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination | 1 day after treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination | 1 day after treatment completion | 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. |
| Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner | Through study completion, an average of 3 months | 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 |
Countries
Bosnia and Herzegovina
Outcome results
None listed