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Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

Primary Purpose

Urinary Tract Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nettle and Cranberry complex capsules
Placebo(starch)
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring Nettle, Cranberry, Prevention, Urinary Tract Infection, Recurrent Infection, Inflammation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
UTI recurrent incidence in 8 weeks
UTI episodes during 8 weeks treatment for each subject

Secondary Outcome Measures

International Prostate Symptom Score (IPSS) Change from Baseline
The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. Score range is 0-35, with higher scores indicating increasing symptom severity.
Overactive Bladder Symptom Score (OABSS) Change from Baseline
OABSS is a valid self-assessment questionnaire, with four questions set according to OAB syndrome to determine the severity of OAB, which includes daytime and nighttime urination frequency, urgency, and urge incontinence. Score range is 0-15, with higher scores indicating increasing symptom severity.
International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline
Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities. Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities.
Bladder diary
Assessment of number of voids, number of leakages, and post void residual.

Full Information

First Posted
May 19, 2023
Last Updated
June 14, 2023
Sponsor
Chung Shan Medical University
Collaborators
Glory Kingdom Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05880602
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chung Shan Medical University
Collaborators
Glory Kingdom Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Nettle, Cranberry, Prevention, Urinary Tract Infection, Recurrent Infection, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will take two capsule of containing starch, twice a daily for 8 weeks.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects will take two capsule of containing nettle and cranberry complex, twice a daily for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nettle and Cranberry complex capsules
Intervention Description
A specific capsule product, containing nettle and cranberry complex will be given to participants for oral intake for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo(starch)
Intervention Description
A specific capsule product, containing starch will be given to participants for oral intake for 8 weeks.
Primary Outcome Measure Information:
Title
UTI-free duration in 8 weeks
Description
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.
Time Frame
on baseline and 8 weeks
Title
UTI recurrent incidence in 8 weeks
Description
UTI episodes during 8 weeks treatment for each subject
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) Change from Baseline
Description
The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. Score range is 0-35, with higher scores indicating increasing symptom severity.
Time Frame
on baseline,4 weeks and 8 weeks
Title
Overactive Bladder Symptom Score (OABSS) Change from Baseline
Description
OABSS is a valid self-assessment questionnaire, with four questions set according to OAB syndrome to determine the severity of OAB, which includes daytime and nighttime urination frequency, urgency, and urge incontinence. Score range is 0-15, with higher scores indicating increasing symptom severity.
Time Frame
on baseline,4 weeks and 8 weeks
Title
International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline
Description
Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities. Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities.
Time Frame
on baseline,4 weeks, and 8 weeks
Title
Bladder diary
Description
Assessment of number of voids, number of leakages, and post void residual.
Time Frame
on baseline,4 weeks, and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Pei-Cheng Lin, PhD
Phone
886-910-371286
Email
pcl@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Phone
886-910-371286
Email
pcl@csmu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
11171002
Citation
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Results Reference
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18611593
Citation
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PubMed Identifier
19917708
Citation
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PubMed Identifier
11118930
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
35579121
Citation
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.
Results Reference
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PubMed Identifier
18490916
Citation
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.
Results Reference
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PubMed Identifier
19441868
Citation
Guay DR. Cranberry and urinary tract infections. Drugs. 2009;69(7):775-807. doi: 10.2165/00003495-200969070-00002.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
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Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

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