Overactive BladderPhase 2NOGO-OABNCT04357223
NOGO for an Overactive Bladder
A Phase 2 study testing extract from Angelica archangelica leaf in people with Overactive Bladder and Nocturia, run by SagaNatura at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Overactive Bladder, Nocturia
- What is being tested?
- extract from Angelica archangelica leaf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 1 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Politecnica de Madrid
Madrid, 28040
Marcela Gonzalez-Gross, Ph.D., +34 91 0677980, marcela.gonzalez.gross@upm.es
About this study
Official title: A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women
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
- Conditions
- Overactive Bladder, Nocturia
- Being tested
- extract from Angelica archangelica leaf, Placebo
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extract from Angelica archangelica leafDrug
A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: extract from Angelica archangelica leaf |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (6)
Reduced number of daytime voids
Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment
Measured: 6 weeks
Reduced number of nocturnal voids (nocturia)
Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment
Measured: 6 weeks
Reduced number of nocturnal voids (nocturia) per hour sleeping time
Reduction in number of voids occurring during sleeping hours corrected by sleeping time as assessed by a 3 day voiding diary before and after treatment
Measured: 6 weeks
Reduced number of voids occurring shortly after the last one
Reduction in number of voids occurring shortly after the preceding void (less than 60, 90 and 120 minutes) as assessed by a 3 day voiding diary before and after treatment
Measured: 6 weeks
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity
Measured: 6 weeks
Improvement of the results of the The International Prostate Symptom Score (IPSS)
A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 May 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SagaNatura
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Responsible party
- Sponsor
- Investigators
- Marcela Gonzalez-Gross, Ph.D., Principal investigator, INEF- Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357223
- Sponsor's protocol ID
- Saga-002
- Acronym
- NOGO-OAB
- Status last verified
- Nov 2020
- First submitted
- 20 Apr 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41368330
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women
- ClinicalTrials.gov ID
- NCT04357223
- Acronym / sponsor ID
- NOGO-OAB / Saga-002
- Conditions
- Overactive Bladder, Nocturia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SagaNaturaIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: extract from Angelica archangelica leaf |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extract from Angelica archangelica leafA standardized extract from Angelica archangelica leaf. Capsule, Twice Daily | Drug | Experimental |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Reduction of urination frequency (number of voids per 24 hours)
Time frame: 6 weeks
Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment
6 secondary outcomes
Reduced number of daytime voids
Time frame: 6 weeks
Reduced number of nocturnal voids (nocturia)
Time frame: 6 weeks
Reduced number of nocturnal voids (nocturia) per hour sleeping time
Time frame: 6 weeks
Reduced number of voids occurring shortly after the last one
Time frame: 6 weeks
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Time frame: 6 weeks
Improvement of the results of the The International Prostate Symptom Score (IPSS)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 41368330Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Gonzalez-Gross, Ph.D. principal investigator
INEF- Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing extract from Angelica archangelica leaf in people with Overactive Bladder and Nocturia, run by SagaNatura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcela Gonzalez-Gross, Ph.D. (34 91 0677980, marcela.gonzalez.gross@upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of urination frequency (number of voids per 24 hours) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.