A randomised, double-blind, placebo-controlled, feasibility study exploring the role of Chinese herbal medicine in the treatment of women with recurrent urinary tract infections

niversity of Southampton (UK)0 sites61 target enrollmentOctober 23, 2014

Overview

Registry

who.int

Start Date

October 23, 2014

End Date

December 30, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

niversity of Southampton (UK)

•Women will be eligible for the trial if they are aged over 18 and under 65 years of age and have reported three or more uncomplicated recurrent lower UTIs in the previous 12 months where at least one episode has been documented as bacterial UTI.

•Women will be excluded from the trial if they:
•1\. Have symptoms of complicated UTIs such as acute pyelonephritis
•2\. Have known hepatic or renal disease
•3\. Are pregnant or breastfeeding
•4\. Have diabetes
•5\. Are taking drugs which may interact with Chinese herbal medicine: cardiac glycosides (Digoxin), warfarin and lithium
•6\. Have psychosis, dementia or terminal illness that may prevent completion of symptom diaries.
•7\. Have commenced a new treatment (conventional or CAM) for RUTIs in the previous 6 months.
•8\. 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\).
•9\. 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.