Chinese herbal medicine for recurrent urinary tract infections
- Conditions
- Recurrent urinary tract infectionsMedDRA version: 17.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-004657-24-GB
- Lead Sponsor
- Southampton University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Women will be eligible for the trial if they are aged over 18 and under 65 years of age and have reported 3 or more uncomplicated recurrent lower UTIs in the previous 12 months where at least one episode has been documented as bacterial UTI.
The reason for the upper age limit of 65 years is that Chinese medicine differentiates several different diagnostic patterns relating to RUTIs. The herbal formulae used for this trial have been designed for a pattern more common in women aged under 65 years. Women over the age of 65 will tend to present with a different pattern to a younger age group and therefore the standardised formula may not be appropriate for them.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Women will be excluded from the trial if they have symptoms of complicated UTI’s such as acute pyelonephritis; have known hepatic or renal disease; are pregnant or breast feeding; have diabetes; have commenced a new treatment for RUTIs in the previous 6 months; are taking drugs which may interact with Chinese herbal medicine: cardiac glycosides (Digoxin), warfarin and lithium; have psychosis, dementia or terminal illness that may prevent completion of symptom diaries. During the trial women will be excluded if they develop significantly raised liver (ALT > 90 U/l) or renal function tests (GFR < 90 mL/mm/1.73m2). Any women who also become pregnant during the trial will also be advised to stop taking the CHM and to inform a member of the study team for further advice. If pregnancy is confirmed, the participant will be asked to withdraw from the intervention in the study and asked for their consent to remain for safety monitoring purposes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method