CHM for RUTIs
Research type
Research Study
Full title
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.
IRAS ID
141599
Contact name
George Lewith
Contact email
Sponsor organisation
University of Southampton
Eudract number
2013-004657-24
Research summary
Exploring the role of Chinese herbal medicine (CHM) in the treatment of recurrent urinary tract infections (RUTIs).
Between 20-30% of women who have had one episode of urinary tract infection (UTI) will have a recurrent UTI and around 25% of these will develop subsequent recurrent episodes. RUTIs have a significant negative effect on quality of life, and a high impact on health care costs. Antibiotics can be effective but growing microbial resistance and unpleasant side effects mean that alternative management strategies require investigation. Some research suggests CHM may help the treatment of RUTIs. This study will provide preliminary data on the treatment effect of CHM and the feasibility of delivering it within primary care.
The trial will involve:
1. A standardised acute and preventative herbal treatment delivered by practice nurses in primary care which will be matched by an identical placebo arm.
2. Individualised treatment delivered by CHM practitioners which will also be matched with a placebo.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 study will last for 16 weeks. Women in the standardised arm will be asked to take 4 x 400mg capsules of herbal powder twice a day as a preventative treatment and 4 capsules four times a day in the event of an acute infection. Women receiving treatment from CHM practitioners will receive powdered herbs with each dose provided in a sealed sachet. Hot water will be added for these herbs to be taken as a herbal tea.
Outcomes will include the number and severity of reported UTIs, participant quality of life and liver and kidney function tests.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1425
Date of REC Opinion
17 Oct 2014
REC opinion
Further Information Favourable Opinion