Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

Sponsor

Chung Shan Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05880602

Collaborator

Glory Kingdom Corporation (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

15.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Dietary Supplement: Nettle and Cranberry complex capsules Dietary Supplement: Placebo(starch)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Placebo dietary supplement for 8 weeks.	Dietary Supplement: Placebo(starch) Take 2 placebo capsules twice daily for 8 weeks
Experimental: Treatment Nettle and Cranberry complex capsules for 8 weeks.	Dietary Supplement: Nettle and Cranberry complex capsules Take 2 Nettle and Cranberry complex capsules twice daily for 8 weeks

Arm

Intervention/Treatment

Placebo Comparator: Control

Placebo dietary supplement for 8 weeks.

Dietary Supplement: Placebo(starch)

Take 2 placebo capsules twice daily for 8 weeks

Experimental: Treatment

Nettle and Cranberry complex capsules for 8 weeks.

Dietary Supplement: Nettle and Cranberry complex capsules

Take 2 Nettle and Cranberry complex capsules twice daily for 8 weeks

Outcome Measures

Primary Outcome Measures

UTI-free duration in 8 weeks [on baseline and 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 [8 weeks]
UTI episodes during 8 weeks treatment for each subject

Secondary Outcome Measures

International Prostate Symptom Score (IPSS) Change from Baseline [on baseline,4 weeks and 8 weeks]
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 [on baseline,4 weeks and 8 weeks]
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 [on baseline,4 weeks, and 8 weeks]
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 [on baseline,4 weeks, and 8 weeks]
Assessment of number of voids, number of leakages, and post void residual.