VertigoHealVertigoNCT05897853
Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness
An observational study of Vertigo and Functional Dizziness, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo, Functional Dizziness, Bilateral Vestibulopathy
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 29 Nov 2021to 5 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients, aged ≥18 years old, diagnosed with bilateral vestibulopathy or functional dizziness were recruited from the Department of Neurology at the Hospital of the Ludwig-Maximilians-University Munich.
Who may be able to join
- Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
- Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
- Symptoms for > 3 months of moderate to severe intensity according to the dizziness handicap inventory [0 (minimum score) -100 (maximum score)] between 30 to 90 points.
- ≥18 years of age
- Legally competent male or female outpatient.
- Signed informed consent.
- Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.
Who cannot join
- Having taken within the last 2 months or currently taking Vertigoheel®.
- Debilitating acute or chronic illness (i.e. psychiatric illnesses).
- History of sensitivity to any component of the study drug under observation.
- Unwilling or unable to comply with all the requirements of the study protocol.
- Any relationship of dependence with the sponsor or with the investigator.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Ludwig Maximilian University
Munich, Bavaria, 81377
About this study
Official title: Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness in a Real-world Setting, Using PRO and QoL - a Non-interventional, Prospective, Mono-center, Observational Study
In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.
Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.
Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.
- Conditions
- Vertigo, Functional Dizziness, Bilateral Vestibulopathy
- Keywords
- real world evidence, non-interventional study, patient reported outcome
- Medical subject headings
- Vertigo, Bilateral Vestibulopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment.
The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Measured: 2 months
Secondary outcomes (4)
Quality of Life (QoL)
Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment.
The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months.
Measured: 2 months
Postural Imbalance
Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment.
Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for "peripheral vestibular deficit" was evaluated for patients with bilateral vestibulopathy, and category five for "phobic postural vertigo" was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).
Measured: 2 months
Depressive Symptoms in Functional Dizziness
Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment.
The PHQ-9, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Measured: 2 months
Anxiety Symptoms in Functional Dizziness
Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start29 Nov 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Michael Strupp, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Strupp, Prof, MD, Principal investigator, Department of Neurology, Ludwig-Maximilians-University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897853
- Sponsor's protocol ID
- 7564
- Acronym
- HealVertigo
- Status last verified
- Apr 2025
- First submitted
- 17 May 2023
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ganeva D, Tiemann R, Duller S, Strupp M. Improvement of vertigo symptoms after 2 months of Vertigoheel treatment: a case series in patients with bilateral vestibulopathy and functional dizziness. Front Neurol. 2023 Oct 5;14:1264884. doi: 10.3389/fneur.2023.1264884. eCollection 2023.
PubMed 37869139
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness in a Real-world Setting, Using PRO and QoL - a Non-interventional, Prospective, Mono-center, Observational Study
- ClinicalTrials.gov ID
- NCT05897853
- Acronym / sponsor ID
- HealVertigo / 7564
- Conditions
- Vertigo, Functional Dizziness, Bilateral Vestibulopathy
- Keywords
- real world evidence, non-interventional study, patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.
Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.
Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients, aged ≥18 years old, diagnosed with bilateral vestibulopathy or functional dizziness were recruited from the Department of Neurology at the Hospital of the Ludwig-Maximilians-University Munich.
Key inclusion criteria (7 listed)
- Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
- Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
- Symptoms for > 3 months of moderate to severe intensity according to the dizziness handicap inventory [0 (minimum score) -100 (maximum score)] between 30 to 90 points.
- ≥18 years of age
- Legally competent male or female outpatient.
Key exclusion criteria (5 listed)
- Having taken within the last 2 months or currently taking Vertigoheel®.
- Debilitating acute or chronic illness (i.e. psychiatric illnesses).
- History of sensitivity to any component of the study drug under observation.
- Unwilling or unable to comply with all the requirements of the study protocol.
- Any relationship of dependence with the sponsor or with the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dizziness Handicap Inventory
Time frame: 2 months
Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
4 secondary outcomes
Quality of Life (QoL)
Time frame: 2 months
Postural Imbalance
Time frame: 2 months
Depressive Symptoms in Functional Dizziness
Time frame: 2 months
Anxiety Symptoms in Functional Dizziness
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37869139Ganeva D, Tiemann R, Duller S, Strupp M. Improvement of vertigo symptoms after 2 months of Vertigoheel treatment: a case series in patients with bilateral vestibulopathy and functional dizziness. Front Neurol. 2023 Oct 5;14:1264884. doi: 10.3389/fneur.2023.1264884. eCollection 2023.
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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.
Michael Strupp, Prof, MD principal investigator
Department of Neurology, Ludwig-Maximilians-University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and Functional Dizziness, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 14 May 2025. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (time frame: 2 months). 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 NCT05897853, 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 14 May 2025.