Use of açaí and counseling in the treatment of tinnitus

Chronic tinnitus: analysis of oxidative metabolism, single counseling session and açaí extract as treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-8z4mhq

Enrollment

Unknown

Registered

2020-07-27

Start date

2018-10-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Tinnitus

Interventions

Placebo group: Placebo was the control product, without active ingredients, made available through starch capsules, used by 15 participants, in their homes, according to the following method of use: t

Behavioural

Dietary supplement

B01.650.940.800.575.912.250.093.480

F02.784.176

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age from 18 years; complaint of chronic tinnitus of at least six months; normal hearing or sensorineural hearing loss from degree to moderate

Exclusion criteria

Exclusion criteria: Neurological diseases; middle ear changes; hearing aid users; illiterate; coagulopaths

Design outcomes

Primary

Measure	Time frame
Evaluate the effectiveness of the experimental treatment, açaí extract with daily supplementation. It is expected to find attenuation of the discomfort with chronic tinnitus. Verified by the Visual Analogue Scale method, Minimum Masking Level, Tinnitus Handicap Inventory, Beck's Anxiety Inventory, The World Health Organization Quality of Life and oxidative stress biomarkers (Dichlorofluoresceinadiacetate, Lipid Peroxidation, Protein carbonylation).	—

Measure

Time frame

Evaluate the effectiveness of the experimental treatment, açaí extract with daily supplementation. It is expected to find attenuation of the discomfort with chronic tinnitus. Verified by the Visual Analogue Scale method, Minimum Masking Level, Tinnitus Handicap Inventory, Beck's Anxiety Inventory, The World Health Organization Quality of Life and oxidative stress biomarkers (Dichlorofluoresceinadiacetate, Lipid Peroxidation, Protein carbonylation).

—

Secondary

Measure	Time frame
Decreased discomfort with tinnitus was observed after treatment, for groups that contained supplementation with açaí, isolated açaí (Visual Analogue Scale p = 0.006; Tinnitus Handicap Inventory p = 0.006), açaí and counseling (Visual Analogue Scale p = 0.002; Tinnitus Handicap Inventory p = 0.014). Placebo Group decreased anxiety scores (p = 0.017) and Minimum Masking Level (p = 0.013). There were no statistically significant differences for quality of life and oxidative stress biomarkers.	—

Measure

Time frame

Decreased discomfort with tinnitus was observed after treatment, for groups that contained supplementation with açaí, isolated açaí (Visual Analogue Scale p = 0.006; Tinnitus Handicap Inventory p = 0.006), açaí and counseling (Visual Analogue Scale p = 0.002; Tinnitus Handicap Inventory p = 0.014). Placebo Group decreased anxiety scores (p = 0.017) and Minimum Masking Level (p = 0.013). There were no statistically significant differences for quality of life and oxidative stress biomarkers.

—

Countries

Brazil

Contacts

Public ContactPós graduação da Comunicação Humana

Universidade Federal de Santa Maria

ppgdch@gmail.com+55-055-32208000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)