Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adult women who already had sexual intercourse
- •diagnosis of non-specific vaginal inflammation by medical examination.
排除标准
- •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
研究组 & 干预措施
Shepherd's Purse extractum oleosum vagitories
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
干预措施: Shepherd's Purse extractum oleosum vagitories (Drug)
Tea tree oil vagitories
Vagitories containing tea tree oil, 200 mg per each vagitorie as active component
干预措施: Tea tree oil vagitories (Drug)
Hyperici extractum oleosum vagitories
Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component
干预措施: Hyperici extractum oleosum vagitories (Drug)
Vagitories - Probiotic
Commercially available vagitories with probiotic
干预措施: Vagitories - Probiotic (Drug)
结局指标
主要结局
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
时间窗: 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.
次要结局
- 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)
研究者
Kemal Durić, PhD
Kemal Duric PhD, Associate Professor
University of Sarajevo