NCT05880602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

May 19, 2023

Last Update Submit

September 24, 2025

Conditions

Urinary Tract Infection

Keywords

NettleCranberryPreventionUrinary Tract InfectionRecurrent InfectionInflammation

Outcome Measures

Primary Outcomes (2)

  • UTI-free duration in 8 weeks

    Comparing the number of days from the beginning of the study to the first recurrence of UTI, and the number of days from each recurrence to the next recurrence between different treatment groups.

    on baseline and 8 weeks

  • UTI recurrent incidence in 8 weeks

    UTI episodes during 8 weeks treatment for each subject

    8 weeks

Secondary Outcomes (4)

  • International Prostate Symptom Score (IPSS) Change from Baseline

    on baseline,4 weeks and 8 weeks

  • Overactive Bladder Symptom Score (OABSS) Change from Baseline

    on baseline,4 weeks and 8 weeks

  • International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline

    on baseline,4 weeks, and 8 weeks

  • Bladder diary

    on baseline,4 weeks, and 8 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Subjects will take two capsule of containing starch, twice a daily for 8 weeks.

Dietary Supplement: Placebo(starch)

Treatment

EXPERIMENTAL

Subjects will take two capsule of containing nettle and cranberry complex, twice a daily for 8 weeks.

Dietary Supplement: Nettle and Cranberry complex capsules

Interventions

Nettle and Cranberry complex capsulesDIETARY_SUPPLEMENT

A specific capsule product, containing nettle and cranberry complex will be given to participants for oral intake for 8 weeks.

Treatment
Placebo(starch)DIETARY_SUPPLEMENT

A specific capsule product, containing starch will be given to participants for oral intake for 8 weeks.

Control

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Related Publications (10)

  • Stamm WE, Norrby SR. Urinary tract infections: disease panorama and challenges. J Infect Dis. 2001 Mar 1;183 Suppl 1:S1-4. doi: 10.1086/318850. No abstract available.

    PMID: 11171002BACKGROUND

  • Harding GK, Ronald AR. The management of urinary infections: what have we learned in the past decade? Int J Antimicrob Agents. 1994 Jun;4(2):83-8. doi: 10.1016/0924-8579(94)90038-8.

    PMID: 18611593BACKGROUND

  • Sivick KE, Mobley HL. Waging war against uropathogenic Escherichia coli: winning back the urinary tract. Infect Immun. 2010 Feb;78(2):568-85. doi: 10.1128/IAI.01000-09. Epub 2009 Nov 16.

    PMID: 19917708BACKGROUND

  • Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol. 2000 Nov;10(8):509-15. doi: 10.1016/s1047-2797(00)00072-7.

    PMID: 11118930BACKGROUND

  • Sihra N, Goodman A, Zakri R, Sahai A, Malde S. Nonantibiotic prevention and management of recurrent urinary tract infection. Nat Rev Urol. 2018 Dec;15(12):750-776. doi: 10.1038/s41585-018-0106-x.

    PMID: 30361493BACKGROUND

  • Kwok M, McGeorge S, Mayer-Coverdale J, Graves B, Paterson DL, Harris PNA, Esler R, Dowling C, Britton S, Roberts MJ. Guideline of guidelines: management of recurrent urinary tract infections in women. BJU Int. 2022 Nov;130 Suppl 3(Suppl 3):11-22. doi: 10.1111/bju.15756. Epub 2022 May 17.

    PMID: 35579121BACKGROUND

  • Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.

    PMID: 18490916BACKGROUND

  • Guay DR. Cranberry and urinary tract infections. Drugs. 2009;69(7):775-807. doi: 10.2165/00003495-200969070-00002.

    PMID: 19441868BACKGROUND

  • Scholes D, Hooton TM, Roberts PL, Stapleton AE, Gupta K, Stamm WE. Risk factors for recurrent urinary tract infection in young women. J Infect Dis. 2000 Oct;182(4):1177-82. doi: 10.1086/315827. Epub 2000 Aug 31.

    PMID: 10979915BACKGROUND

  • Wan X, Wu C, Xu D, Huang L, Wang K. Toileting behaviours and lower urinary tract symptoms among female nurses: A cross-sectional questionnaire survey. Int J Nurs Stud. 2017 Jan;65:1-7. doi: 10.1016/j.ijnurstu.2016.10.005. Epub 2016 Oct 21.

    PMID: 28027949BACKGROUND

MeSH Terms

Conditions

Urinary Tract InfectionsReinfectionInflammation

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRecurrenceDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Pei-Cheng Lin, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 30, 2023

Study Start

July 5, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

TW(1)