Last updated: November 9, 2020
Sponsor: SagaNatura
Overall Status: Active - Recruiting
Phase
2
Condition
Nocturia
Enuresis
Overactive Bladder
Treatment
N/AClinical Study ID
NCT04357223
Saga-002
Ages 30-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids pernight and/or less then 2 hours between voids at least half time of the day (question 2IPSS)
Exclusion
Exclusion Criteria:
- 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 hematuriaor 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 6months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
- Medical history or active conditions which, in the opinion of the principalinvestigator (PI) and physicians participating in the study would prohibitparticipation in the study. This includes, but is not limited to: diabetes, cancer,renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (<6months) myocardial infarction or unstable coronary artery disease.
- Psychiatric diseases and medication.
- Use of NoGO or other products containing A. archangelica extract within the previous 2months prior to randomisation.
- Known allergy to compound or any other ingredients of NoGo.
- Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusionif they have a wash out period.
- Receipt of an investigational product within 30 days prior to enrolment or expectedreceipt during this study.
Study Design
Total Participants: 200
Study Start date:
May 01, 2020
Estimated Completion Date:
March 01, 2021
Connect with a study center
Universidad Politecnica de Madrid
Madrid, 28040
SpainActive - Recruiting
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