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Evaluation of antioxidant therapy in presbycusis: results of a prospective, randomized, double-blind and controlled clinical trial.

"Evaluation of antioxidant therapy on hearing improvement in presbycusis patients 60 and older: results of a prospective, randomized, double-blind and controlled clinical trial"

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000667011
Enrollment
120
Registered
2010-08-16
Start date
2010-08-23
Completion date
2010-12-13
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The study aimed to evaluate the efficacy of treatment with anti-oxidants in presbycusis, or deafness in the elderly. For this, the volunteers will be divided into four groups and each group will receive one of the following medications: ginkgo biloba, alpha lipoic acid + vitamin C, vitamin E + papaverine and placebo. After six months the hearing will be tested and compared with an initial test to check for hearing improvement with any of these therapies.

Interventions

There are four treatment groups. Group 1: ginkgo biloba, Group 2: alpha lipoic acid with vitamin C, Group 3: papaverine hydrochloride with vitamin E, and Group 4 (Comparator): starch pill. Dry extract of ginkgo biloba 120 mg once a day, oral tablet taken daily for a total of 6 months, alpha lipoic acid 60 mg in combination with vitamin C 600 mg once a day, oral tablet taken daily for a total of 6 months, and vitamin E 400 mg combined with papaverine hydrochloride 100 mg once a day, oral tablet t

There are four treatment groups. Group 1: ginkgo biloba, Group 2: alpha lipoic acid with vitamin C, Group 3: papaverine hydrochloride with vitamin E, and Group 4 (Comparator): starch pill. Dry extract of ginkgo biloba 120 mg once a day, oral tablet taken daily for a total of 6 months, alpha lipoic acid 60 mg in combination with vitamin C 600 mg once a day, oral tablet taken daily for a total of 6 months, and vitamin E 400 mg combined with papaverine hydrochloride 100 mg once a day, oral tablet taken daily for a total of 6 months.

Sponsors

CDA
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults with diagnosis of presbycusis by hearing tests and clinical evaluation.

Exclusion criteria

Will be excluded individuals with other causes for hearing loss, known allergy to any substances in question or with medical contraindications to using them. Patients taking anticoagulants or with coagulation disorders and diabetics will also be excluded from the sample.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026