Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05545514
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2022-09-14
Brief Title:
Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iHOM
Brief Summary:
The aim of the study is to determine the efficacy of individualised homeopathic drug treatment potency C200 and C1000 compared to placebo in females age 1865 with recurrent urinary tract infections per definition 2 UTI in 6 months and or 3 UTI in 9 months
Detailed Description:
The World Health Organization has declared the problem of antibiotic resistance to be a global crisis and the European Union has defined among other things the reduction of antibiotic use in its strategies to avoid the development of resistance Recurrent UTIs are one of the most common infectious diseases contributing to a multiple of multidrug- resistant extra intestinal pathogenic E coli increasing morbidity and mortality due to many treatment failures and hospital admissions which leads to increased healthcare costs There is therefore an urgent need to optimize appropriate usage in order to minimize the burden of disease for the patients and the health care services while maintaining treatment safety at the same time
In Germany it is currently recommended to treat uncomplicated UTIs symptomatically as long as no dangerous course of the disease can be expected but different treatment options aiming to decrease the frequency of UTI treated with antibiotics have shown only limited success Thus the symptom load of the affected patients as well as prescription rates for antibiotics remain high and treatment options are warranted by patients and physicians
Homeopathy has shown relevant clinical effects for other recurrent infectious diseases and a reduction of the frequency of recurrent UTIs with individualised homeopathic treatment iHOM has been observed in practice In this study we therefore aim to test the efficacy of this treatment approach as an add-on therapy to the treatment standard in a double-blind placebo-controlled randomised clinical trial
In Germany it is currently recommended to treat uncomplicated UTIs symptomatically as long as no dangerous course of the disease can be expected but different treatment options aiming to decrease the frequency of UTI treated with antibiotics have shown only limited success Thus the symptom load of the affected patients as well as prescription rates for antibiotics remain high and treatment options are warranted by patients and physicians
Homeopathy has shown relevant clinical effects for other recurrent infectious diseases and a reduction of the frequency of recurrent UTIs with individualised homeopathic treatment iHOM has been observed in practice In this study we therefore aim to test the efficacy of this treatment approach as an add-on therapy to the treatment standard in a double-blind placebo-controlled randomised clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None