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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

Primary Purpose

Non Specific Vaginitis

Status
Completed
Phase
Phase 4
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Shepherd's Purse extractum oleosum vagitories
Tea tree oil vagitories
Hyperici extractum oleosum vagitories
Vagitories - Probiotic
Sponsored by
University of Sarajevo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Specific Vaginitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Kemal Duric

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Shepherd's Purse extractum oleosum vagitories

Tea tree oil vagitories

Hyperici extractum oleosum vagitories

Vagitories - Probiotic

Arm 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

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

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

Commercially available vagitories with probiotic

Outcomes

Primary Outcome Measures

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.

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
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
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

Full Information

First Posted
August 31, 2020
Last Updated
September 17, 2020
Sponsor
University of Sarajevo
Collaborators
Institution for Health Protection of Women and Motherhood, University of Tuzla
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1. Study Identification

Unique Protocol Identification Number
NCT04558697
Brief Title
Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
Official Title
Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sarajevo
Collaborators
Institution for Health Protection of Women and Motherhood, University of Tuzla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shepherd's Purse extractum oleosum vagitories
Arm Type
Experimental
Arm 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
Arm Title
Tea tree oil vagitories
Arm Type
Experimental
Arm Description
Vagitories containing tea tree oil, 200 mg per each vagitorie as active component
Arm Title
Hyperici extractum oleosum vagitories
Arm Type
Experimental
Arm Description
Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component
Arm Title
Vagitories - Probiotic
Arm Type
Active Comparator
Arm Description
Commercially available vagitories with probiotic
Intervention Type
Drug
Intervention Name(s)
Shepherd's Purse extractum oleosum vagitories
Intervention Description
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Tea tree oil vagitories
Intervention Description
Tea tree oil vagitories will be administered once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Hyperici extractum oleosum vagitories
Intervention Description
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Vagitories - Probiotic
Intervention Description
Vagitories - Probiotic will be administered once daily for 5 days
Primary Outcome Measure Information:
Title
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
Description
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 Outcome Measure Information:
Title
Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination
Description
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
Title
Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahir Becic, PhD
Organizational Affiliation
Universiyt of Sarajevo Faculty of Pharmacy
Official's Role
Study Chair
Facility Information:
Facility Name
Kemal Duric
City
Sarajevo
State/Province
Canton Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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