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

Phase 4

Completed

• Conditions: Non Specific Vaginitis
• Interventions: Drug: Hyperici extractum oleosum vagitories; Drug: Shepherd's Purse extractum oleosum vagitories; Drug: Tea tree oil vagitories; Drug: Vagitories - Probiotic

• Registration Number: NCT04558697
• Lead Sponsor: University of Sarajevo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Primary Completion: 2019-06-21
• Study Completion: 2019-09-30
• Study First Submitted: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperici extractum oleosum vagitories	Hyperici extractum oleosum vagitories	Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component
Shepherd's Purse extractum oleosum vagitories	Shepherd's Purse extractum oleosum vagitories	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	Tea tree oil vagitories	Vagitories containing tea tree oil, 200 mg per each vagitorie as active component
Vagitories - Probiotic	Vagitories - Probiotic	Commercially available vagitories with probiotic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kemal Duric; 🇧🇦 Sarajevo, Canton Sarajevo, Bosnia and Herzegovina