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

University of Sarajevo

Status and phase

Completed

Phase 4

Conditions

Non Specific Vaginitis

Treatments

Drug: Tea tree oil vagitories

Drug: Hyperici extractum oleosum vagitories

Drug: Vagitories - Probiotic

Drug: Shepherd's Purse extractum oleosum vagitories

Study type

Interventional

Funder types

Other

Identifiers

NCT04558697

03/7-1053/19

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

210 participants in 4 patient groups

Shepherd's Purse extractum oleosum vagitories

Experimental group

Description:

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

Treatment:

Drug: Shepherd's Purse extractum oleosum vagitories

Tea tree oil vagitories

Experimental group

Description:

Vagitories containing tea tree oil, 200 mg per each vagitorie as active component

Treatment:

Drug: Tea tree oil vagitories

Hyperici extractum oleosum vagitories

Experimental group

Description:

Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component