Phase
Condition
Urinary Tract Infections
Treatment
One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
Clinical Study ID
Ages 18-64 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females, age 18 < 64 years
Signed informed consent
Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrentUTI for at least three months before baseline
No product or dosage change of systemic hormonal treatment (including oralanticonception) for at least three months before baseline
Female participants who are not capable of bearing children or who use a method ofcontraception that is medically approved by the health authority of the respectivecountry.
This includes:
A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea withserum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after abilateral ovariectomy with or without hysterectomy or sterilization by means oftubal ligation
A woman capable of bearing child is defined as follows: a woman who isphysiologically capable of becoming pregnant, including women whose occupation,lifestyle or sexual orientation exclude sexual intercourse with a male partner andwomen whose partners have been sterilized by vasectomy or other measures.
Medically-approved methods of contraception can include the following: hormonalcontraceptives, intrauterine device and double barrier method. Acceptable preventivemeasures can include total abstinence at the discretion of the investigator, incases where compliance is ensured because of the study participant's age,occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar,ovulation, symptothermal methods or abstinence until the 4th day after theovulation) as well as coitus interruptus are not acceptable methods ofcontraception.
A reliable method of contraception must be used for the entire duration of thestudy.
Exclusion
Exclusion Criteria:
- Individual symptomatology of the patient indicates the prescription of a HMP whichis not available within this clinical trial 2. Pregnancy or breast feeding afterpregnancy 3. Women with a complicated urinary tract infection (including infectionsoccurring 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 urinarytract or the pelvic floor 5. Known hypersensivity against the study medication orthe recommended on demand medication (Ibuprofen) 6. Homoeopathic therapy forrecurrent UTIs during the last 6 months before baseline 7. Postmenopausal womanWITHOUT previous attempt of a therapy with locally applicate (vaginal) oestrogen 8.Serious acute or chronic organic disease or serious mental disorder, including
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 pathology
- Patients not able to declare meaningful informed consent on their own (e.g. withlegal guardian), or other vulnerable patients (e.g. under arrest) 10. Simultaneousparticipation in any other clinical trial 11. Employees or family members of thesponsor or investigators
Study Design
Study Description
Connect with a study center
Klinikum rechts der Isar, Department of Nephrology
München, Bayern 81675
GermanySite Not Available
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