Clinical trial NCT05880602: Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
Official title: Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Nettle
Cranberry
Prevention
Urinary Tract Infection
Recurrent Infection
Inflammation
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Glory Kingdom Corporation
First posted: 2023-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates whether the oral intake of a nettle and cranberry complex capsule may prevent recurrent urinary tract infection (rUTI). Participants will be aged between 30 - 75 years of age, with confirmed diagnosis of UTI status. The participants will be assessed for several parameters and asked to take 2 nettle and cranberry complex capsules twice daily for 8 weeks. The parameters will include international prostate symptoms score (IPSS), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD), and urine routine.

Detailed description: Urinary tract infections (UTIs) are one of the most common bacterial infections affecting women. UTI occurs in 50-80% of women in the general population. About one in four women with one UTI episode will go on to develop frequent recurrences.

Recurrent urinary tract infection (rUTI) is defined as repeated UTI with a frequency of at least two episodes in the preceding six months or three episodes in the past year. rUTI has been regarded as a substantial global healthcare problem.

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of rUTI are randomly assigned to control group or treatment group, and asked to orally intake 2 capsules of either placebo or nettle and cranberry complex capsules twice daily. Participants will be assessed for parameters, including international prostate symptoms score (IPSS) (male only), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD) and urine routine. The assessments are conducted at baseline, 4 weeks, and 8 weeks after the oral intake period. The parameters are used to compare and evaluate whether the nettle and cranberry complex capsule can prevention rUTI.

Eligibility criteria: Inclusion Criteria:

* aged between 30 and 75 years
* at least two episodes in 6 months, or at least three episodes of a UTI in 12 months.

Exclusion Criteria:

* pregnancy women
* diabetes
* History of anatomical urogenital anomalies, urogenital tract surgery
* History of acute or chronic renal failure, nephrolithiasis
* History of intestinal diseases causing malabsorption
* Anticoagulant medication in the last month
* immunocompromise
* Known allergy or intolerance to cranberry

Primary outcomes:
measure: UTI-free duration in 8 weeks
timeFrame: on baseline and 8 weeks
measure: UTI recurrent incidence in 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS) Change from Baseline
timeFrame: on baseline,4 weeks and 8 weeks
measure: Overactive Bladder Symptom Score (OABSS) Change from Baseline
timeFrame: on baseline,4 weeks and 8 weeks
measure: International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline
timeFrame: on baseline,4 weeks, and 8 weeks
measure: Bladder diary
timeFrame: on baseline,4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: David Pei-Cheng Lin, PhD
role: PRINCIPAL_INVESTIGATOR
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