Effect of maritime pine bark extract, Pycnogenol, on chronic tinnitus (ringing or buzzing in the ears)
| ISRCTN | ISRCTN16884561 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16884561 |
| Secondary identifying numbers | TinniPYC V.03 |
- Submission date
- 15/02/2023
- Registration date
- 03/03/2023
- Last edited
- 09/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Tinnitus is one of the most common ear symptoms, defined as conscious awareness of sound in the absence of an external auditory stimulus. In most cases, tinnitus develops as a result of various causes (e.g. sudden hearing loss, noise trauma, ototoxic drugs, head injury or depression). It is assumed that oxidative stress plays a crucial role in the etiopathogenesis of tinnitus. Currently, no universal cure exists for patients suffering from tinnitus and the available treatment is not sufficient for their quality of life. Pycnogenol® (PYC) is natural standardised extract from pine bark and has multiple health benefits. It has strong antioxidant properties, stimulates activity of antioxidant enzymes, protects vascular endothelium, improves microcirculatory function, stimulates the production of NO by stimulating NO synthase, and others. This double-blind, randomized, placebo-controlled study aims to investigate the effect of daily use of PYC (150 mg per day) on symptoms of tinnitus, quality of life and markers of oxidative stress in patients with chronic tinnitus for 3 months.
Who can participate?
Adults aged 18 to 70 years suffering from chronic tinnitus for at least 6 months.
What does the study involve?
In the randomised, double-blind placebo-controlled study, the improvement effects of PYC (PYC- group) on the management of patients with chronic tinnitus will be compared with placebo (PL-group). Patients who meet the inclusion criteria, after initial medical investigation (complete medical history and examination, demographic and anthropometric data, audiometry, questionnaire about quality of life) will be allocated to one of the two arms of the project (PYC or PL-group) in ratio 1:1, according to a computer-generated random sequence (visit 1). Patients will be administered 150 mg PYC or Placebo for 3 months. Subsequently, patients will be examined by audiometry, to determine changes in intensity, noise and frequency of tinnitus and masking tone change, and patients will fill out a questionnaire about quality of life (visit 2). At each visit, blood samples will be taken. The randomisation will be performed by the statistician, who will have no contact with the participants. The research team and participants will be unaware of the group assignments.
What are the possible benefits and risks of participating?
Participants who receive Pycnogenol® may benefit from the reduction of the symptoms of tinnitus and improvement of their quality of life. There are no known risks to participants taking part in this study.
Where is the study run from?
1. Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Comenius University, Bratislava, Slovakia
2. Department of Otorhinolaryngology - Head and Neck Surgery, Faculty of Medicine and University Hospital, Comenius University Bratislava, Slovakia
When is the study starting and how long is it expected to run for?
May 2022 to December 2025
Who is funding the study?
Horphag Research Ltd, Geneva, Switzerland
Who is the main contact?
RNDr. Paduchová Zuzana, PhD.
zuzana.paduchova@fmed.uniba.sk
Contact information
Scientific
Sasinkova 2
Bratislava
81108
Slovakia
 ORCID ID |
0000-0002-8488-3888 |
|---|---|
| Phone | +421 2 90119 411 |
| zuzana.paduchova@fmed.uniba.sk |
Study information
| Study design | inerventional double-blinded randomized and placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Medical and other records |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | TinniPYC: Pycnogenol and chronic tinnitus |
| Study acronym | TinniPYC |
| Study hypothesis | The study aims to investigate whether daily supplementation with Pycnogenol® in capsules (150mg/day) is able to reduce the symptoms of tinnitus, improve quality of life and to affect parameters of oxidative stress in patients with chronic tinnitus for 3 months. |
| Ethics approval(s) | Approved 16/12/2022, Ethics Board of St. Cyril and Methodius Hospital, University Hospital in Bratislava, Slovakia (Antolská 11, 851 07 Bratislava, SLovakia; +421 2 68672 730; eticka.komisia@pe.unb.sk), ref: EK/2/12/2022 |
| Condition | Chronic tinnitus |
| Intervention | Participants randomised to active or placebo group will be required to take three capsules a day for 3 months: 1. Active intervention: 50 mg of standardised extract from pine bark – Pycnogenol® per capsules 2. Placebo intervention: maltodextrin without the active substances, identically packaged as active. Both interventions will be prepared by Horphag Research Ltd. (Geneva, Switzerland). Eligible subjects were allocated in a 1:1 ratio to the two arms of the study (active and placebo) according to a computer-generated random sequence using block randomisation with a block-size of four. The randomisation was performed by a study statistician, who had no participant contact. Participants were enrolled and assigned sequentially to interventions by the doctor. The allocation sequence sealed in an envelope will be kept by the project coordinator in case of an emergency requirement to break the code. The allocation sequence was not available to any member of the research team until the databases had been completed and locked. |
| Intervention type | Supplement |
| Primary outcome measure | Changes in clinical symptoms are measured by audiometry at baseline and 3 months: 1. Tinnitus intensity 2. Tinnitus noise and frequency 3. Masking tone |
| Secondary outcome measures | 1. Quality of life measured usig Tinnitus Functional Index (TFI) questionnaires at baseline and 3 months, 2. Basic biochemical parameters (glucose, insulin, uric acid, urea), lipid profile (total cholesterol, HDL, LDL, TAG) , liver enzymes (ALT, AST, ALP), blood count and cortisol levels measured in the accredited Clinical biochemistry and haematology laboratory at baseline and 3 months after intervention, 3. Markers of oxidative stress (DNA damage, AOPP, LPx, TBARS, nitrothyrosine, total oxidant status), levels of paraoxonase with lactonase activity (PON-L) and cytokine IL-10 measured in plasma/serum or whole blood at baseline and 3 month after intervention, 4. Total antioxidant status (FRAP, TEAC) and activities of antioxidant enzymes (SOD, GPx, CAT) measured in plasma or erythrocytes lysate at baseline and 3 months of intervention. |
| Overall study start date | 01/05/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 80 participants, 40 in active group and 40 in placebo |
| Participant inclusion criteria | 1. Adults aged between 18 and 70 years 2. Chronic tinnitus for a minimum of 6 months 3. Patients who are willing to sign an informed consent 4. Patients who are willing to provide two blood samples |
| Participant exclusion criteria | 1. Age <18 and >70 years. 2. Pregnant or breastfeeding women. 3. Patients with a history of ear surgery. 4. Patients with vestibular schwannoma hearing impairment beyond age-related sensor neurological disorder, more serious neurological or internal disease (tumour, stroke, vascular stenosis, Meniere's disorder, etc.). 5. Patients who are taking blood thinners. 6. Patients who are unable/unwilling to sign an informed consent. 7. Patients who are unable/unwilling to provide samples of biological material as needed. |
| Recruitment start date | 22/08/2023 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- Slovakia
Study participating centres
Antolská 11
Bratislava
851 07
Slovakia
Medical School
Sasinkova 2
Bratislava
81108
Slovakia
Sponsor information
Industry
71, avenue Louis Casaï
Geneva
CH-1216 Cointrin
Slovakia
| Phone | +41 (0)22 710 26 26 |
|---|---|
| carolina.burki@horphag.com | |
| Website | http://www.pycnogenol.com |
"ROR" |
https://ror.org/003n34405 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from zuzana.paduchova@fmed.uniba.sk |
Editorial Notes
09/09/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/09/2024 to 30/09/2025.
2. The overall study end date was changed from 31/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 01/06/2025 to 01/06/2026.
05/12/2023: The recruitment start date was changed from 06/03/2023 to 22/08/2023.
17/02/2023: Trial's existence confirmed by Ethics Board of St. Cyril and Methodius Hospital.
