EUCTR2021-002214-14-DE招募中1 期
Individualized homeopathy to reduce the use of antibiotics in women with recurring uncomplicated urinary tract infections
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1.Females, age <65 years
- •2.Signed informed consent
- •3.Documented recurrent UTI (i.e. = 2 UTI in 6 months and/ or = 3 UTI in 12 months)
- •4.No change of other prophylactic treatment (e.g. Urovaxom, estrogen) for recurrent UTI for at least three months before baseline
- •5.No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
- •6.Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Individual symptomatology of the patient indicates the prescription of
- •a HMP which is not available within this clinical trial
- •2.Pregnancy or breast feeding after pregnancy
- •3.Women with a complicated urinary tract infection (including infections
- •occurring due to anatomical abnormalities (e.g. an obstruction, renal
- •tract calculi, hydro nephrosis), infections occurring due to an immune
- •compromised state (e.g. HIV, immune suppressive therapy), and
- •recurrent infections despite adequate treatment (multi-drug resistant
- •organisms or atypical organisms))
- •4.Surgery of the urinary tract or the pelvic floor
- •5.Known hypersensivity against the study medication or the
- •recommended on demand medication (Ibuprofen)
- •6.Homoeopathic therapy for recurrent UTIs during the last 3 months
- •before baseline
- •7.Postmenopausal woman WITHOUT previous attempt of a therapy
- •with locally applicate (vaginal) oestrogen
- •8.Serious acute or chronic organic disease or serious mental disorder,
- •-diseases requiring immune suppressive therapy
- •-diabetes mellitus type 1 or 2 with an HbA1c > 7%
- •-any acute organic failure
- •-any advanced chronic organic failure (e.g. grade 3 or more)
- •-active cancer
- •-active (=clinically unstable) epileptic, cardiovascular or other organic
- •9.Patients not able to declare meaningful informed consent on their own
- •(e.g. with legal guardian), or other vulnerable patients (e.g. under
- •10.Simultaneous participation in any other clinical trial
- •11.Employees or family members of the sponsor or investigators
研究者
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