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

NCT04558697 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-09-22

No results posted yet for this study

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.

Conditions

  • Non Specific Vaginitis

Interventions

DRUG

Shepherd's Purse extractum oleosum vagitories

Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days

DRUG

Tea tree oil vagitories

Tea tree oil vagitories will be administered once daily for 5 days

DRUG

Hyperici extractum oleosum vagitories

Hyperici extractum oleosum vagitories will be administered once daily for 5 days

DRUG

Vagitories - Probiotic

Vagitories - Probiotic will be administered once daily for 5 days

Sponsors & Collaborators

  • Institution for Health Protection of Women and Motherhood

    collaborator UNKNOWN

  • University of Tuzla

    collaborator UNKNOWN

  • University of Sarajevo

    lead OTHER

Principal Investigators

  • Fahir Becic, PhD · Universiyt of Sarajevo Faculty of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2019-06-21
Completion
2019-09-30

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04558697 on ClinicalTrials.gov