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

NCT04558697 | Completed Phase 4

• 1 other identifier: 03/7-1053/19
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Specific Vaginitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1 day after treatment completion

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

  Through study completion, an average of 3 months

Study Arms (4)

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

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

Drug: Tea tree oil vagitories

Hyperici extractum oleosum vagitories

EXPERIMENTAL

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

Drug: Hyperici extractum oleosum vagitories

Vagitories - Probiotic

ACTIVE COMPARATOR

Commercially available vagitories with probiotic

Drug: Vagitories - Probiotic

Interventions

Shepherd's Purse extractum oleosum vagitories DRUG

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

Shepherd's Purse extractum oleosum vagitories

Tea tree oil vagitories DRUG

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

Tea tree oil vagitories

Hyperici extractum oleosum vagitories DRUG

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

Hyperici extractum oleosum vagitories

Vagitories - Probiotic DRUG

Vagitories - Probiotic will be administered once daily for 5 days

Vagitories - Probiotic

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult women who already had sexual intercourse
• diagnosis of non-specific vaginal inflammation by medical examination.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sarajevo: lead
• Institution for Health Protection of Women and Motherhood: collaborator
• University of Tuzla: collaborator

Study Sites (1)

Kemal Duric

Sarajevo, Canton Sarajevo, 71000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fahir Becic, PhD

  Universiyt of Sarajevo Faculty of Pharmacy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kemal Duric PhD, Associate Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 22, 2020
• Study Start: March 21, 2019
• Primary Completion: June 21, 2019
• Study Completion: September 30, 2019
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)