Non Specific Vaginitis Clinical Trial
Official title:
Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
| Verified date | September 2020 |
| Source | University of Sarajevo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | September 30, 2019 |
| Est. primary completion date | June 21, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Bosnia and Herzegovina | Kemal Duric | Sarajevo | Canton Sarajevo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sarajevo | Institution for Health Protection of Women and Motherhood, University of Tuzla |
Bosnia and Herzegovina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 |