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

Sponsor

University of Sarajevo (Other)

Overall Status

Completed

CT.gov ID

NCT04558697

Collaborator

Institution for Health Protection of Women and Motherhood (Other), University of Tuzla (Other)

210

Enrollment

Location

Arms

6.3

Actual Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Specific Vaginitis	Drug: Shepherd's Purse extractum oleosum vagitories Drug: Tea tree oil vagitories Drug: Hyperici extractum oleosum vagitories Drug: Vagitories - Probiotic	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2019

Actual Primary Completion Date :

Jun 21, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Shepherd's Purse extractum oleosum vagitories Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Experimental: Tea tree oil vagitories Vagitories containing tea tree oil, 200 mg per each vagitorie as active component	Drug: Tea tree oil vagitories Tea tree oil vagitories will be administered once daily for 5 days
Experimental: Hyperici extractum oleosum vagitories Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component	Drug: Hyperici extractum oleosum vagitories Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Active Comparator: Vagitories - Probiotic Commercially available vagitories with probiotic	Drug: Vagitories - Probiotic Vagitories - Probiotic will be administered once daily for 5 days

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kemal Duric	Sarajevo	Canton Sarajevo	Bosnia and Herzegovina	71000

Sponsors and Collaborators

University of Sarajevo
Institution for Health Protection of Women and Motherhood
University of Tuzla

Investigators

Study Chair: Fahir Becic, PhD, Universiyt of Sarajevo Faculty of Pharmacy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kemal Durić, PhD, Kemal Duric PhD, Associate Professor, University of Sarajevo

ClinicalTrials.gov Identifier:

NCT04558697

Other Study ID Numbers:

03/7-1053/19

First Posted:

Sep 22, 2020

Last Update Posted:

Sep 22, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2020