NCT04357223

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

April 20, 2020

Last Update Submit

November 9, 2020

Conditions

Overactive BladderNocturia

Outcome Measures

Primary Outcomes (1)

  • Reduction 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

    6 weeks

Secondary Outcomes (6)

  • Reduced number of daytime voids

    6 weeks

  • Reduced number of nocturnal voids (nocturia)

    6 weeks

  • Reduced number of nocturnal voids (nocturia) per hour sleeping time

    6 weeks

  • Reduced number of voids occurring shortly after the last one

    6 weeks

  • Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL
Drug: extract from Angelica archangelica leaf

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

extract from Angelica archangelica leafDRUG

A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily

Experimental
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politecnica de Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (1)

  • Lopez-Seoane J, Gesteiro E, Castro-Alija MJ, Quesada-Gonzalez C, Perez-Ruiz M, Gonzalez-Gross M. Effects of Angelica archangelica Extract on Overactive Bladder: A Pilot Randomized Controlled Trial. Food Sci Nutr. 2025 Dec 8;13(12):e71258. doi: 10.1002/fsn3.71258. eCollection 2025 Dec.

    PMID: 41368330DERIVED

MeSH Terms

Conditions

Urinary Bladder, OveractiveNocturia

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcela Gonzalez-Gross, Ph.D.

    INEF- Universidad Politecnica de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela Gonzalez-Gross, Ph.D.

CONTACT

34 91 0677980marcela.gonzalez.gross@upm.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

May 1, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)