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NOGO for an Overactive Bladder

NCT ID: NCT04357223

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-03-01

Brief Summary

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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

Detailed Description

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Conditions

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Overactive Bladder Nocturia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

Group Type EXPERIMENTAL

extract from Angelica archangelica leaf

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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extract from Angelica archangelica leaf

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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Politecnica de Madrid

OTHER

Sponsor Role collaborator

SagaNatura

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcela Gonzalez-Gross, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

INEF- Universidad Politecnica de Madrid

Locations

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Universidad Politecnica de Madrid

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marcela Gonzalez-Gross, Ph.D.

Role: CONTACT

Phone: 34 91 0677980

Email: [email protected]

Facility Contacts

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Marcela Gonzalez-Gross, Ph.D.

Role: primary

Other Identifiers

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Saga-002

Identifier Type: -

Identifier Source: org_study_id