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NCT Number: NCT04558697

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

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.

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Key information

Conditions

Non Specific Vaginitis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kemal Duric

Sarajevo, Canton Sarajevo, 71000, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shepherd's Purse extractum oleosum vagitories

Drug

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

Tea tree oil vagitories

Drug

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

Hyperici extractum oleosum vagitories

Drug

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

Vagitories - Probiotic

Drug

Vagitories - Probiotic will be administered once daily for 5 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Sarajevo

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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