Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

NCT ID: NCT05880602

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Placebo(starch)

Intervention Type DIETARY_SUPPLEMENT

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

Treatment

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

Group Type EXPERIMENTAL

Nettle and Cranberry complex capsules

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nettle and Cranberry complex capsules

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

Intervention Type DIETARY_SUPPLEMENT

Placebo(starch)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glory Kingdom Corporation

UNKNOWN

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Pei-Cheng Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 11171002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18611593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19917708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11118930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30361493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35579121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18490916 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19441868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10979915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28027949 (View on PubMed)

Other Identifiers

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CS2-23025

Identifier Type: -

Identifier Source: org_study_id

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