Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001116910
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
26/10/2011
Date last updated
26/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
prevention of noise induced hearing loss by n- acetyl cysteine
Scientific title
Evaluation of effect of N-acetyl cysteine on prevention of noise induced hearing loss in textile workers in Yazd-Iran
Secondary ID [1] 273247 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss 279008 0
Condition category
Condition code
Ear 279193 279193 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
n- acetyl cysteine: Effervescent tablet 600 mg (oral tablet), twice a day over a total of 14 days
Intervention code [1] 269583 0
Treatment: Drugs
Intervention code [2] 269592 0
Prevention
Comparator / control treatment
sugar pill
Control group
Placebo

Outcomes
Primary outcome [1] 279830 0
hearing threshold (transient threshold shift)
Timepoint [1] 279830 0
baseline ( pre and post shift measurement) and at 2 weeks after intervention ( pre and post shift measurement)
Secondary outcome [1] 294528 0
nil
Timepoint [1] 294528 0
nil

Eligibility
Key inclusion criteria
1. exposure to noise >= 85 dbA at work environment
2. at least 1 year work duration
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
conductive hearing loss, past exposure to organic solvents or noise, diabetes, hypertension, thyroid dysfunction, head trauma, head surgery, acoustic trauma, ototoxic drug consumption, chronic otitis media, congenital hearing loss,
consumption of supplementary drugs or vitamines for >= 6 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 3916 0
Iran, Islamic Republic Of
State/province [1] 3916 0

Funding & Sponsors
Funding source category [1] 270074 0
University
Name [1] 270074 0
Shahid Sadoughi University of medical scienses
Country [1] 270074 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Sadoughi University of medical scienses
Address
Shahid Rahnemun hospital, Farrokhi street, Yazd. post code :8913893111
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 269053 0
None
Name [1] 269053 0
Address [1] 269053 0
Country [1] 269053 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33290 0
Address 33290 0
Country 33290 0
Phone 33290 0
Fax 33290 0
Email 33290 0
Contact person for public queries
Name 16537 0
Davari MohammadHossein
Address 16537 0
Shahid Rahnemun hospital, Farrokhi street, Yazd. post code: 8913893111
Country 16537 0
Iran, Islamic Republic Of
Phone 16537 0
+98 9133044764
Fax 16537 0
Email 16537 0
drmhdavari@gmail.com
Contact person for scientific queries
Name 7465 0
loukzadeh ziba
Address 7465 0
Shahid Rahnemun hospital, Farrokhi street, Yazd. post code: 8913893111
Country 7465 0
Iran, Islamic Republic Of
Phone 7465 0
+98 9131576119
Fax 7465 0
Email 7465 0
dr.loukzadeh@gmail.com

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.