Tokyo, Oct. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061454) titled 'The effects of cranberry extract supplementation on urinary symptoms in healthy adults' on Oct. 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Others
Condition:
Condition - Healthy adults with urinary concerns
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of cranberry extract supplementation on urinary symptoms (urinary frequency, urgency, intimate zone discomfort, etc.) in healthy adults with urinary concerns
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take cranberry extract capsules 100mg (proanthocyanidin 9% specification) for 4 weeks (28 days)
Interventions/Control_2 - Take placebo capsules for 4 weeks (28 days)
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Female
Key inclusion criteria - (1) Persons who are generally judged as healthy
(2) Persons who can give voluntary written informed consent
(3) Persons with OABSS total score of 3 or more
(4) Persons with OABSS question 3 (urgency) score of 2 or more (urinary urgency at least once per week)
(5) Persons not diagnosed with lower urinary tract disease, overactive bladder, or sexually transmitted infections
Key exclusion criteria - (1) Persons with suspected overactive bladder or prostatic hyperplasia
(2) Persons currently under urological treatment
(3) Persons taking health foods that affect urination (cranberry, saw palmetto, pumpkin seed, pomegranate, etc.) once or more per week, or persons continuously taking medicines with similar effects to this study
(4) Persons who changed/newly started supplements within past 4 weeks
(5) Pregnant, breastfeeding, or planning pregnancy during study period
(6) Persons who participated in another human trial within past 4 weeks
(7) Persons deemed unsuitable by the investigator
(8) Persons experiencing intimate zone discomfort (itching, irritation, etc.) or swelling sensation in the face or legs
(9) Persons who have urinary tract infections, urinary stones, kidney stones, ureteral stones, gallstones, or infections such as chlamydia or syphilis
Target Size - 30
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2026 Year 05 Month 01 Day
Date of IRB - 2026 Year 03 Month 08 Day
Anticipated trial start date - 2026 Year 05 Month 07 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070222
Disclaimer: Curated by HT Syndication.