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
About this trial
This is an interventional treatment trial for Non Specific Vaginitis
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
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
NCT ID
NCT04558697
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
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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