Chinese herbal medicine in the treatment of women with recurrent urinary tract infections

• Register: ISRCTN
• Last refreshed on: 30 March 2020
• Main ID: ISRCTN95402719
• Date of registration: 23/10/2014
• Prospective Registration: Yes
• Primary sponsor: University of Southampton (UK)
• Public title: Chinese herbal medicine in the treatment of women with recurrent urinary tract infections
• Scientific 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
• Date of first enrolment: 05/01/2015
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN95402719
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Andrew Flower

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria:
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.


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: Primary Care; Subtopic: Infectious diseases and microbiology, Primary care; Disease: All Diseases
Infections and Infestations

Intervention(s)

During the trial herbal medicines will be administered either as standardised capsules or as individualised herbal granules to be dissolved in hot water to make a herbal drink.

Standardised herbs will be administered as 0.4 g capsules (four pills taken twice a day [b.d.] for preventative treatment and four pills taken four times a day [q.d.] in the event of an acute infection).

The individualised arm of the trial will follow the routine practice of CHM, which involves qualified practitioners.

Follow Up Length: 6 month(s); Study Entry : Registration and One or More Randomisations

Primary Outcome(s)

Current outcome measures as of 09/01/2019:
1. Symptom diaries indicating the severity of acute and recurrent UTI symptoms (reporting dysuria, haematuria, frequency during day and night, 'smelly urine', 'tummy pain', generally feeling unwell, and restriction of daily activities).
2. Rate of UTI recurrence, as reported in the symptom diaries completed for each acute UTI episode during the active phase of the trial.
3. In addition to the diary for acute UTIs participants will be asked to complete an end of month diary in which they record number of days with symptoms, changes in presentation, time lost from work, and how easy it has been to comply with the herbal medicine regime. These diaries will provide information on the rate and severity of acute infection but also on the impact of low grade, chronic infection on the lives of women. Participants will be asked to complete both an acute and a monthly diary for the 6-month follow-up of the trial to enable the evaluation of any longer term changes in infection rates.
4. Use of antibiotics for acute UTIs, elicited from symptom diaries and cross-referenced with GP notes
5. In addition we will use EQ5D, liver and renal function tests, and qualitative research.

Previous outcome measures:
1. Symptom diaries indicating the severity of acute and recurrent UTI symptoms (reporting dysuria, haematuria, frequency during day and night, 'smelly urine', 'tummy pain', generally feeling unwell, and restriction of daily activities).
2. Rate of UTI recurrence, as reported in the symptom diaries completed for each acute UTI episode during the active phase of the trial.
3. In addition to the diary for acute UTIs participants will be asked to complete an end of month diary in which they record number of days with symptoms, changes in presentation, time lost from work, and how easy it has been to comply with the herbal medicine regime. These diaries will provide information on the rate and severity of acute infection but also on the impact of low grade, chronic infection on the lives of women. Participants will be asked to complete both an acute and a monthly diary for the 6-month follow-up of the trial to enable the evaluation of any longer term changes in infection rates.
4. Use of antibiotics for acute UTIs, elicited from symptom diaries and cross-referenced with GP notes.
5. In addition we will use The Borkevic and Devilly questionnaire, MYMOP, The Morisky Medication Adherence Scale, EQ5D, liver and renal function tests, and qualitative research.

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

17290

2013-004657-24

Source(s) of Monetary Support

National Institute of Health Research (NIHR) (UK); Grant Codes: NIHR-PDF-2011-04-027

Ethics review

Status:
Approval date:
Contact:

Surrey Borders NRES; 17/10/2014; ref: 14/LO/1425

Results

• Results available: Yes
• Date Completed: 30/12/2017