Effect of maritime pine bark extract, Pycnogenol, on chronic tinnitus (ringing or buzzing in the ears)

TinniPYC: Pycnogenol and chronic tinnitus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16884561

Enrollment

Registered

2023-03-03

Start date

2023-08-22

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic tinnitus Ear, Nose and Throat

Interventions

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 c

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Age 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Slovakia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026