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

University of Sarajevo210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Non Specific Vaginitis

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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