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临床试验/NCT04747041
NCT04747041进行中(未招募)不适用

Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
15
试验地点
2
主要终点
adherence to phyto-aromatherapy treatment

研究概览

简要总结

Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis.

The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem.

several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances.

There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years.

The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities.

Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Women aged 18 or older.
  • Affiliated to social security.
  • Presenting recurrent cystitis defined by a frequency of at least 4 episodes per year.
  • For women of childbearing age: effective contraception followed for at least 3 months prior to the start of the study and agreeing to keep it throughout the study period
  • Available to consult a phyto-aromatherapy pharmacist for an initial consultation and then every 3 months (M3, 6,9, 12) and then at 18 months.
  • Having been previously explored according to good practice and informed
  • Having signed the informed consent

排除标准

  • Pregnant or breastfeeding women
  • Severe visceral deficiencies in the previous year.
  • Individualised psychiatric pathology.
  • Other progressive infectious pathologies requiring antibiotic treatment.
  • Taking anticoagulants.
  • Concomitant intake of non-drug treatments.

结局指标

主要结局

adherence to phyto-aromatherapy treatment

时间窗: 12th month

The scale called "treatment compliance" ranges from 1 to 10. A score of 1 means not at all observant and 10 means very observant.

次要结局

  • Antibiotic treatments(12 months)
  • Evaluation of the evolution of bacterial resistance on phenotypes isolated from the cytobacteriological examination of urine(From date of inclusion until the date of documented episode of cystitis, assessed up to 18 months)
  • Number of cystitis(12 months)
  • Patients' overall satisfaction(12 months)
  • Recording adverse events(18 months)
  • The benefit persisting at 6 months after stopping treatment with phyto-aromatherapy(During 6 months after stopping treatment (patient stop treatment at Month12 so between the 12th and 18th month))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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