This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily
Placebo
Universidad Politecnica de Madrid
Madrid, Spain
RECRUITINGReduction of urination frequency (number of voids per 24 hours)
Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment
Time frame: 6 weeks
Reduced number of daytime voids
Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment
Time frame: 6 weeks
Reduced number of nocturnal voids (nocturia)
Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment
Time frame: 6 weeks
Reduced number of nocturnal voids (nocturia) per hour sleeping time
Reduction in number of voids occurring during sleeping hours corrected by sleeping time as assessed by a 3 day voiding diary before and after treatment
Time frame: 6 weeks
Reduced number of voids occurring shortly after the last one
Reduction in number of voids occurring shortly after the preceding void (less than 60, 90 and 120 minutes) as assessed by a 3 day voiding diary before and after treatment
Time frame: 6 weeks
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity
Time frame: 6 weeks
Improvement of the results of the The International Prostate Symptom Score (IPSS)
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A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity
Time frame: 6 weeks