Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis
Status: Recruiting

Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female patients aged 18 years and older. Patients with a confirmed diagnosis of chronic bacterial cystitis. Patients with exacerbation of chronic cystitis based on typical symptoms of exacerbation of the disease with a severity of 7 points or more in accordance wuth ACSS. The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis. Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential). Availability of a signed patient information sheet and informed consent form for participation in the clinical trial.  Exclusion Criteria:  Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination. Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination. Suspicion of bladder tuberculosis. Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis. Decompensation of diabetes mellitus, immunodeficiency of any etiology, malignant cancer of any localization, severe circulatory insufficiency (cardiovascular disease with functional class IV according to the classification of the New York Heart Association, 1964). Unstable angina pectoris or myocardial infarction within the previous 6 months. Chronic kidney disease (classes С3-5 А3). Hepatic impairment (Child-Pugh class C). Patients who require medicinal products prohibited for use in this study. Exacerbation or decompensation of chronic conditions affecting the patient's ability to participate in the clinical trial. Malabsorption syndrome, including congenital or acquired lactase deficiency or other disaccharidase insufficiency, galactosemia. Hypersensitivity to any component of the medicinal products used in the treatment. Pregnancy, breastfeeding; childbirth less than 3 months prior to study enrollment, unwillingness to comply with contraceptive methods during the study. The medications listed in the Prohibited Concomitant Medication section were administered within 4 weeks prior to enrollment. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or comply with the administration of the study drug. History of mental diseases, alcoholism, or drug abuse that, in the investigator's opinion, may interfere with the successful completion of trial procedures. Participation in other clinical trials within 3 months prior to enrollment. The patient belongs to the investigational site personnel directly involved in the study, closest relatives of the investigator. The closest relatives are defined as spouse, parents, children or siblings, regardless of whether they are natural or adopted. The patient works for the company OOO "NPF "MATERIA MEDICA HOLDING", being an employee of the company, a temporary contract worker or an appointed official responsible for performing the trial, or their close relative. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult