Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institution for Health Protection of Women and Motherhood | UNKNOWN |
| University of Tuzla | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shepherd's Purse extractum oleosum vagitories | Experimental | 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 |
|
| Tea tree oil vagitories | Experimental | Vagitories containing tea tree oil, 200 mg per each vagitorie as active component |
|
| Hyperici extractum oleosum vagitories | Experimental | Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component |
|
| Vagitories - Probiotic | Active Comparator | Commercially available vagitories with probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shepherd's Purse extractum oleosum vagitories | Drug | Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fahir Becic, PhD | Universiyt of Sarajevo Faculty of Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemal Duric | Sarajevo | Canton Sarajevo | 71000 | Bosnia and Herzegovina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tea tree oil vagitories | Drug | Tea tree oil vagitories will be administered once daily for 5 days |
|
| Hyperici extractum oleosum vagitories | Drug | Hyperici extractum oleosum vagitories will be administered once daily for 5 days |
|
| Vagitories - Probiotic | Drug | Vagitories - Probiotic will be administered once daily for 5 days |
|
| 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 |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided