Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000667011
Ethics application status
Approved
Date submitted
3/08/2010
Date registered
16/08/2010
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of antioxidant therapy in presbycusis: results of a prospective, randomized, double-blind and controlled clinical trial.
Scientific title
"Evaluation of antioxidant therapy on hearing improvement in presbycusis patients 60 and older: results of a prospective, randomized, double-blind and controlled clinical trial"
Secondary ID [1] 252359 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
presbycusis 257872 0
Condition category
Condition code
Alternative and Complementary Medicine 258032 258032 0 0
Other alternative and complementary medicine
Ear 258091 258091 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256922 0
Treatment: Other
Comparator / control treatment
starch pill 100 mg once a day, oral tablet taken daily for a total of 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 258881 0
Primary Outcome: hearing improvement in an audiometric test
Timepoint [1] 258881 0
Timepoint: at 6 months after intervention commencement
Secondary outcome [1] 265032 0
Efects on tinnitus
Timepoint [1] 265032 0
nil

Eligibility
Key inclusion criteria
Adults with diagnosis of presbycusis by hearing tests and clinical evaluation.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
120 volunteers numbered containers will be randomly assigned to four different groups:30 individuals will take dry extract of Ginkgo biloba, 30 a-lipoic acid in combination with vitamin C, 30 papaverine hydrochloride in combination with vitamin E and 30 placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be randomised by using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2010
Actual
23/08/2010
Date of last participant enrolment
Anticipated
Actual
13/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 2796 0
Brazil
State/province [1] 2796 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257375 0
Other Collaborative groups
Name [1] 257375 0
CDA - Centro do Deficiente Auditivo
Country [1] 257375 0
Brazil
Primary sponsor type
Other Collaborative groups
Name
CDA
Address
Borges Lagoa streeet, 783 – 2nd.floor - room 21 cep 04023-062 Vila Clementino - Sao Paulo – Sao Paulo - Brazil
Country
Brazil
Secondary sponsor category [1] 256611 0
None
Name [1] 256611 0
nil
Address [1] 256611 0
nil
Country [1] 256611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259392 0
Ethics Committee of the Federal University of Sao Paulo / Hospital Sao Paulo
Ethics committee address [1] 259392 0
Botucatu street, 572-1 st. floor - room 14 cep 04023-062 - Sao Paulo / Brazil
Ethics committee country [1] 259392 0
Brazil
Date submitted for ethics approval [1] 259392 0
Approval date [1] 259392 0
02/07/2010
Ethics approval number [1] 259392 0
CEP 0723/10

Summary
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.
Trial website
Trial related presentations / publications
Evaluation of antioxidant treatment in presbyacusis: prospective, placebo-controlled, double-blind, randomised trial.
Polanski JF, Cruz OL.
J Laryngol Otol. 2013 Feb;127(2):134-41. doi: 10.1017/S0022215112003118.
Public notes

Contacts
Principal investigator
Name 31458 0
Dr Jose Fernando Polanski
Address 31458 0
Rua Borges Lagoa, 783
Vila Clementino
ZIp code 04038-031
Sao Paulo-SP
Brasil
Country 31458 0
Brazil
Phone 31458 0
55 11 5576 4848 add 2427
Fax 31458 0
Email 31458 0
[email protected]
Contact person for public queries
Name 14705 0
Dr Jose Fernando Polanski
Address 14705 0
Borges Lagoa street, 783 – 2nd.floor - room 21 cep 04023-062 Vila Clementino - Sao Paulo – Sao Paulo
Country 14705 0
Brazil
Phone 14705 0
+55 41 99749470
Fax 14705 0
nil
Email 14705 0
[email protected]
Contact person for scientific queries
Name 5633 0
Dr Jose Fernando Polanski
Address 5633 0
Borges Lagoa street, 783 – 2nd.floor - room 21 cep 04023-062 Vila Clementino - Sao Paulo – Sao Paulo
Country 5633 0
Brazil
Phone 5633 0
+55 11 99749470
Fax 5633 0
Email 5633 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.