Status:
UNKNOWN
NOGO for an Overactive Bladder
Lead Sponsor:
SagaNatura
Collaborating Sponsors:
Universidad Politecnica de Madrid
Conditions:
Overactive Bladder
Nocturia
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS)
Exclusion
- High alcohol consumption (males \> 3 beers/day (36 g alcohol), females \>2 beers/day --
- (24 g alcohol), but we take weekly average.
- Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
- Chronic incontinence.
- Recurrent urinary tract infections (3 or more times per year).
- Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy
- Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
- Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (\<6 months) myocardial infarction or unstable coronary artery disease.
- Psychiatric diseases and medication.
- Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation.
- Known allergy to compound or any other ingredients of NoGo.
- Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusion if they have a wash out period.
- Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04357223
Start Date
May 1 2020
End Date
March 1 2021
Last Update
November 12 2020
Active Locations (1)
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1
Universidad Politecnica de Madrid
Madrid, Spain, 28040