NOGO for an Overactive Bladder

Last updated: November 9, 2020
Sponsor: SagaNatura
Overall Status: Active - Recruiting

Phase

2

Condition

Nocturia

Enuresis

Overactive Bladder

Treatment

N/A

Clinical Study ID

NCT04357223
Saga-002
  • Ages 30-70
  • All Genders

Study 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

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
    Spain

    Active - Recruiting

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