Non Specific VaginitisPhase 4NCT04558697
Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
A Phase 4 study testing Shepherd's Purse extractum oleosum vagitories, Tea tree oil vagitories and Hyperici extractum oleosum vagitories in people with Non Specific Vaginitis, run by University of Sarajevo at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non Specific Vaginitis
- What is being tested?
- Shepherd's Purse extractum oleosum vagitories, Tea tree oil vagitories and Hyperici extractum oleosum vagitories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 21 Mar 2019to 30 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult women who already had sexual intercourse
- diagnosis of non-specific vaginal inflammation by medical examination.
Who cannot join
- 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,
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- immunodeficiency disorder,
- severe chronic illness,
- previous radiotherapy, chemotherapy and biological therapy
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Kemal Duric
Sarajevo, Canton Sarajevo, 71000
About this study
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
- Being tested
- Shepherd's Purse extractum oleosum vagitories, Tea tree oil vagitories, Hyperici extractum oleosum vagitories, Vagitories - Probiotic
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shepherd's Purse extractum oleosum vagitoriesDrug
Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Tea tree oil vagitoriesDrug
Tea tree oil vagitories will be administered once daily for 5 days
Hyperici extractum oleosum vagitoriesDrug
Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Vagitories - ProbioticDrug
Vagitories - Probiotic will be administered once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Shepherd's Purse extractum oleosum vagitories | Experimental | 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 Receives: Drug: Shepherd's Purse extractum oleosum vagitories |
| Tea tree oil vagitories | Experimental | Vagitories containing tea tree oil, 200 mg per each vagitorie as active component Receives: Drug: Tea tree oil vagitories |
| Hyperici extractum oleosum vagitories | Experimental | Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component Receives: Drug: Hyperici extractum oleosum vagitories |
| Vagitories - Probiotic | Active comparator | Commercially available vagitories with probiotic Receives: Drug: Vagitories - Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day after treatment completion
Secondary outcomes (2)
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.
Measured: 1 day after treatment completion
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
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start21 Mar 2019
- Primary completion21 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sarajevo
- Sponsor type
- University, hospital or other
- Collaborators
- Institution for Health Protection of Women and Motherhood, University of Tuzla
- Responsible party
- Principal investigator, Kemal Durić, PhD, University of Sarajevo
- Investigators
- Fahir Becic, PhD, Study chair, Universiyt of Sarajevo Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558697
- Sponsor's protocol ID
- 03/7-1053/19
- Status last verified
- Sep 2020
- First submitted
- 31 Aug 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
- ClinicalTrials.gov ID
- NCT04558697
- Acronym / sponsor ID
- 03/7-1053/19
- Conditions
- Non Specific Vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of SarajevoUniversity, hospital or other
- Collaborators
- Institution for Health Protection of Women and Motherhood, University of Tuzla
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shepherd's Purse extractum oleosum vagitories | Experimental | Drug: Shepherd's Purse extractum oleosum vagitoriesVagitories 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 |
| Tea tree oil vagitories | Experimental | Drug: Tea tree oil vagitoriesVagitories containing tea tree oil, 200 mg per each vagitorie as active component |
| Hyperici extractum oleosum vagitories | Experimental | Drug: Hyperici extractum oleosum vagitoriesVagitories containing Hyperici extractum oleosum 32% (w/w) as active component |
| Vagitories - Probiotic | Active comparator | Drug: Vagitories - ProbioticCommercially available vagitories with probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult women who already had sexual intercourse
- diagnosis of non-specific vaginal inflammation by medical examination.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shepherd's Purse extractum oleosum vagitoriesShepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days | Drug | Shepherd's Purse extractum oleosum vagitories |
| Tea tree oil vagitoriesTea tree oil vagitories will be administered once daily for 5 days | Drug | Tea tree oil vagitories |
| Hyperici extractum oleosum vagitoriesHyperici extractum oleosum vagitories will be administered once daily for 5 days | Drug | Hyperici extractum oleosum vagitories |
| Vagitories - ProbioticVagitories - Probiotic will be administered once daily for 5 days | Drug | Vagitories - Probiotic |
Primary outcome
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
Time frame: 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.
2 secondary outcomes
Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination
Time frame: 1 day after treatment completion
Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahir Becic, PhD study chair
Universiyt of Sarajevo Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shepherd's Purse extractum oleosum vagitories, Tea tree oil vagitories and Hyperici extractum oleosum vagitories in people with Non Specific Vaginitis, run by University of Sarajevo at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination (time frame: 1 day after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.