Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05880602
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D000084063', 'term': 'Reinfection'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UTI-free duration in 8 weeks', 'timeFrame': 'on baseline and 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.'}, {'measure': 'UTI recurrent incidence in 8 weeks', 'timeFrame': '8 weeks', 'description': 'UTI episodes during 8 weeks treatment for each subject'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS) Change from Baseline', 'timeFrame': 'on baseline,4 weeks and 8 weeks', '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.'}, {'measure': 'Overactive Bladder Symptom Score (OABSS) Change from Baseline', 'timeFrame': 'on baseline,4 weeks and 8 weeks', '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.'}, {'measure': 'International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline', 'timeFrame': 'on baseline,4 weeks, and 8 weeks', 'description': 'Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities.\n\nAssessment 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.'}, {'measure': 'Bladder diary', 'timeFrame': 'on baseline,4 weeks, and 8 weeks', 'description': 'Assessment of number of voids, number of leakages, and post void residual.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nettle', 'Cranberry', 'Prevention', 'Urinary Tract Infection', 'Recurrent Infection', 'Inflammation'], 'conditions': ['Urinary Tract Infection']}, 'referencesModule': {'references': [{'pmid': '11171002', 'type': 'BACKGROUND', 'citation': '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': '18611593', 'type': 'BACKGROUND', 'citation': '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': '19917708', 'type': 'BACKGROUND', 'citation': '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': '11118930', 'type': 'BACKGROUND', 'citation': "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': '30361493', 'type': 'BACKGROUND', 'citation': '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': '35579121', 'type': 'BACKGROUND', '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.'}, {'pmid': '18490916', 'type': 'BACKGROUND', '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.'}, {'pmid': '19441868', 'type': 'BACKGROUND', 'citation': 'Guay DR. Cranberry and urinary tract infections. Drugs. 2009;69(7):775-807. doi: 10.2165/00003495-200969070-00002.'}, {'pmid': '10979915', 'type': 'BACKGROUND', '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.'}, {'pmid': '28027949', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nRecurrent 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 30 and 75 years\n* at least two episodes in 6 months, or at least three episodes of a UTI in 12 months.\n\nExclusion Criteria:\n\n* pregnancy women\n* diabetes\n* History of anatomical urogenital anomalies, urogenital tract surgery\n* History of acute or chronic renal failure, nephrolithiasis\n* History of intestinal diseases causing malabsorption\n* Anticoagulant medication in the last month\n* immunocompromise\n* Known allergy or intolerance to cranberry'}, 'identificationModule': {'nctId': 'NCT05880602', 'briefTitle': 'Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection', 'orgStudyIdInfo': {'id': 'CS2-23025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects will take two capsule of containing starch, twice a daily for 8 weeks.', 'interventionNames': ['Dietary Supplement: Placebo(starch)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects will take two capsule of containing nettle and cranberry complex, twice a daily for 8 weeks.', 'interventionNames': ['Dietary Supplement: Nettle and Cranberry complex capsules']}], 'interventions': [{'name': 'Nettle and Cranberry complex capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A specific capsule product, containing nettle and cranberry complex will be given to participants for oral intake for 8 weeks.', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo(starch)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A specific capsule product, containing starch will be given to participants for oral intake for 8 weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'David Pei-Cheng Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glory Kingdom Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}