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NCT Number: NCT05880602

Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection

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.

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Key information

Conditions

Urinary Tract Infection Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Reinfection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nettle and Cranberry complex capsules

Dietary Supplement

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

Placebo(starch)

Dietary Supplement

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

Primary outcomes

  1. UTI-free duration in 8 weeks

    Time frame: 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.

  2. UTI recurrent incidence in 8 weeks

    Time frame: 8 weeks

    UTI episodes during 8 weeks treatment for each subject

Secondary outcomes

  1. International Prostate Symptom Score (IPSS) Change from Baseline

    Time frame: 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.

  2. Overactive Bladder Symptom Score (OABSS) Change from Baseline

    Time frame: 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.

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

    Time frame: 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.

  4. Bladder diary

    Time frame: on baseline,4 weeks, and 8 weeks

    Assessment of number of voids, number of leakages, and post void residual.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • Glory Kingdom Corporation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 30, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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