Use of a supplement called Memovigor-2 in tinnitus (a condition where a person hears a ringing or buzzing sound in their ears)
| ISRCTN | ISRCTN16025480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16025480 |
| Secondary identifying numbers | 14549-18/11/2019 |
- Submission date
- 20/03/2023
- Registration date
- 05/04/2023
- Last edited
- 20/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Tinnitus is a common condition where people hear sounds like ringing or whistling in their ears, even when there is no external noise present. It affects 15-20% of people, especially older adults. Most people have a mild form of tinnitus in quiet rooms, but it can be a problem if it's bothersome or affects hearing. It's usually associated with hearing loss, but it can happen to anyone. We don't know exactly what causes tinnitus, so it's hard to treat. A new drug called Memovigor2, made from natural ingredients, has been suggested as a treatment for recent-onset tinnitus. This type of tinnitus may be easier to treat because the brain is more adaptable. The aim of this study is to see if Memovigor2 can help treat tinnitus.
Who can participate?
Adults aged 18-70 years who suffer from recent-onset tinnitus.
What does the study involve?
Participants are asked to join this study when they come to our Audiology & Neurotology Department suffering from tinnitus that began during the last 12 months. Participants are randomly allocated to one of two groups. Those in the first group are given Memovigor-2 tablets, one daily, for 3 months. Those in the second group are given dummy tablets, also 1 tablet daily for 3 months. Participants of both groups complete questionnaires and objective audiological tests at the beginning and after 3 months of treatment. The study lasts until testing 80 patients of each group. The study is randomized double-blind, because participants are randomly allocated to one of the two groups, and they don’t know if they are given the drug or the dummy. Also, the examiner does not know to which group belongs each patient.
What are the possible benefits and risks of participating?
By taking part in this study there are no risks of physical injury or harm. The only known adverse reaction of the drug is a small effect on blood coagulation, which can present as bruises, or bleeding that does not stop easily with pressure. However, patients with blood coagulation disorders or using anticoagulants are excluded from the study. For the participants taking the drug, the benefit is a possible improvement of their tinnitus. Participants in the second group, if the drug is proven useful, may gain by taking the drug after the end of the study. Also, many patients with recent-onset tinnitus may benefit from the results of this study.
Where is the study run from?
Audiology & Neurotology Department, Tzaneio General Hospital, Piraeus, Greece
When is the study starting and how long is it expected to run for?
December 2019 to September 2023
Who is funding the study?
The study is self-funded. However, the pharmaceutical company Bionat has provided the drug and the dummies.
Who is the main contact?
Dimitrios Balatsouras, dbalats@hotmail.com
Contact information
Public
Audiology & Neurotology Department
Tzaneio General Hospital of Piraeus
1 Afentouli Str.
Piraeus
18536
Greece
 ORCID ID |
0000-0001-9064-0201 |
|---|---|
| Phone | +30 2104592644 |
| hospital@tzaneio.gr |
Scientific
Audiology & Neurotology Department
Tzaneio General Hospital of Piraeus
1 Afentouli Str.
Pireaus
18536
Greece
| Phone | +30 2104592644 |
|---|---|
| grpros@tzaneio.gov.gr |
Principal Investigator
Audiology & Neurotology Department
Tzaneio General Hospital of Piraeus
1 Afentouli Str.
Pireaus
18536
Greece
| Phone | +30 2104592644 |
|---|---|
| dbalats@hotmail.com |
Study information
| Study design | Single-centre randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Memovigor-2 improves tinnitus in patients with recent onset disease: A randomized placebo-controlled study |
| Study hypothesis | To assess improvement of tinnitus using Memovigor-2 in patients with tinnitus of recent onset |
| Ethics approval(s) |
Approved 05/12/2019, Institutional Review Board of Tzaneio General Hospital of Piraeus (1 Afentouli, Piraeus, 18536, Greece; +30 2132081000; epistimonico.symvulio@tzaneio.gov.gr), ref: 14549/05-12-2019 |
| Condition | Tinnitus |
| Intervention | Patients participating in the research group (50%) are given 1 tablet 900 mg of Memovigor 2 (Bionat, Athens, Greece) daily for 3 months. Similar use of placebo is used in the remaining 50%, the control group. A sealed envelope with either drug or placebo is provided to the subjects of the study for the randomisation process. |
| Intervention type | Supplement |
| Primary outcome measure | Tinnitus change is measured using Tinnitus Handicap Inventory questionnaire (THI) at baseline and 3 months |
| Secondary outcome measures | Current secondary outcome measures as of 04/07/2023: 1. Tinnitus severity is measured using Mini Tinnitus Questionnaire at baseline and 3 months 2. Evaluation of perceptional quality of tinnitus using specific measures of tinnitus perception (tinnitus loudness matching, tinnitus pitch matching, tinnitus minimum masking level, residual inhibition of tinnitus) at baseline and 3 months 3. Evaluation of hearing is measured using audiometry at baseline and 3 months 4. Perception of tinnitus change due to intervention measured using the Patient's Global Impression of Change (PGIC) at baseline and 3 months Previous secondary outcome measures: 1. Tinnitus severity is measured using Mini Tinnitus Questionnaire at baseline and 3 months 2. Objective tinnitus evaluation is measured using objective tinnitus measurement tests (tinnitus loudness matching, tinnitus pitch matching, tinnitus minimum masking level, residual inhibition of tinnitus) at baseline and 3 months 3. Evaluation of hearing is measured using audiometry at baseline and 3 months. |
| Overall study start date | 04/11/2019 |
| Overall study end date | 06/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 17 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 80 per group (80 patients and 80 controls) |
| Total final enrolment | 204 |
| Participant inclusion criteria | 1. Age 18 - 70 years 2. Suffering from tinnitus 3. Recent onset disease ≤12 months |
| Participant exclusion criteria | 1. Patients with otosclerosis 2. Chronic otitis media 3. Hypo- or hyperthyroidism 4. Diabetes mellitus 5. Uncontrolled hypertension 6. Hypercholesterolemia 7. Coagulation disorders 8. Use of anticoagulants |
| Recruitment start date | 09/12/2019 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- Greece
Study participating centre
1 Afentouli Str
Piraeus
18536
Greece
Sponsor information
Hospital/treatment centre
1 Afentouli Str.
Piraeus
18536
Greece
| Phone | +30 6945547980 |
|---|---|
| info@bionat.gr | |
| Website | https//www:tzaneio.gov.gr |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 24/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 20/02/2024: The study was published in the journal of Frontiers in Pharmacology. Previous publication and dissemination plan: Planned publication in a PubMed-indexed peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Dimitrios Balatsouras, dbalats@hotmail.com, participant level raw data, after publication for 5 years. The data will be anonymous and will be shared by E-mail to members of the Biomedical Community for scientific analysis. The data will be anonymous and no patient consent is required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/07/2023 | No | No | ||
| Results article | 24/01/2024 | 09/02/2024 | Yes | No |
Additional files
Editorial Notes
20/02/2024: The publication and dissemination plan was updated. The intention to publish date was changed from 01/09/2023 to 24/01/2024.
09/02/2024: Publication reference added.
05/07/2023: Internal review.
04/07/2023: The following changed were made:
1. Uploaded protocol (not peer reviewed).
2. The secondary outcome measures.
3. The total final enrolment was changed from 200 to 204.
05/04/2023: Trial's existence confirmed by the Institutional Review Board of Tzaneio General Hospital of Piraeus (Greece).
