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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12610000667011 |
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Date of registration:
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16/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of antioxidant therapy in presbycusis: results of a prospective, randomized, double-blind and controlled clinical trial.
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Scientific title:
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"Evaluation of antioxidant therapy on hearing improvement in presbycusis patients 60 and older: results of a prospective, randomized, double-blind and controlled clinical trial" |
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Date of first enrolment:
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23/08/2010 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12610000667011.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Dr Jose Fernando Polanski
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Address:
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Borges Lagoa street, 783 – 2nd.floor - room 21 cep 04023-062 Vila Clementino - Sao Paulo – Sao Paulo
Brazil |
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Telephone:
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+55 41 99749470 |
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Email:
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jfpolanski@gmail.com |
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Affiliation:
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Name:
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Dr Jose Fernando Polanski
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Address:
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Borges Lagoa street, 783 – 2nd.floor - room 21 cep 04023-062 Vila Clementino - Sao Paulo – Sao Paulo
Brazil |
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Telephone:
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+55 11 99749470 |
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Email:
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jfpolanski@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
60 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Ear - Other ear disorders
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Alternative and Complementary Medicine - Other alternative and complementary medicine
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presbycusis;
presbycusis
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Intervention(s)
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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.
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Primary Outcome(s)
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Primary Outcome: hearing improvement in an audiometric test[Timepoint: at 6 months after intervention commencement]
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Secondary Outcome(s)
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Efects on tinnitus[nil]
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Source(s) of Monetary Support
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CDA - Centro do Deficiente Auditivo
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of the Federal University of Sao Paulo / Hospital Sao Paulo
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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