The goal of this randomized clinical trial is evaluation of the effects of N-Acetylcysteine and Ginseng on prevention of Noise Induced Hearing Loss (NIHL).Inclusion criteria include Male workers; hearing better than 40 dBHL; ear health; no using of ototoxic drugs or food supplements or magnesium and exclusion criteria include male workers more than 50 years; hearing loss more than 40 dBHL; pathology of external, middle or inner ear and use of ototoxic drugs or food supplements or magnesium.
In 48 factory male workers which are exposed to continuous noise, audiometry, high frequency audiometry , tympanometry and otoacoustic emission (OAE) will be measured prior to a work shift. Then these workers will divided randomly into 3 groups. One group (case) will receive Acetylcysteine for two weeks, the other group (case) will receive Ginseng for two weeks and the last one will not receive any drug. After two weeks, measurements will be repeated.
This study will perform from February until March 2013 in textile factory.Primary outcomes are hearing threshold and otoacoustic emission amplitude.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301158698N9
Registration date:2013-03-08, 1391/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-08, 1391/12/18
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation
Expected recruitment start date
2013-02-06, 1391/11/18
Expected recruitment end date
2013-03-14, 1391/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of N-Acetylcysteine and Ginseng on Prevention of Noise Induced Hearing Loss in male workers
Public title
Effect of N-Acetylcysteine and Ginseng on prevention of noise Induced Hearing Loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male worker; Hearing better than 40 dBHL; Ear Health; No using of ototoxic drugs or food supplements or magnesium; Continous noise more than 80 dBA in work place
Exclusion criteria: Male workers more than 50 years; Hearing Loss more than 40 dBHL; Pathology of external, middle or inner ear; Use of ototoxic drugs or food supplements or magnesium; Continous noise less than 80 dBA in work place
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Koodakiar street, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Approval date
2013-01-27, 1391/11/08
Ethics committee reference number
26246
Health conditions studied
1
Description of health condition studied
Noise Induced Hearing Loss
ICD-10 code
H83.3
ICD-10 code description
Noise effects on inner ear
Primary outcomes
1
Description
Hearing threshold
Timepoint
Before Intervention, Two weeks after intervention
Method of measurement
Audiometer Instrument
Secondary outcomes
1
Description
Otoacoustic Emission amplitude
Timepoint
Before Intevnention, Two weeks after intervention
Method of measurement
Otoacoustic emission Instrument
Intervention groups
1
Description
administration of N-Acetylcysteine tablets 600 mg oral 2 numbers for one time a day during two weeks and Ginseng capsule 100 mg 2 numbers for one time a day during two weeks (case group)
Category
Treatment - Drugs
2
Description
No administration of drug (control group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azadi textile factory
Full name of responsible person
Ahmad Hoorzad
Street address
Azadi square,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Safamanesh
Street address
Koodakiar street, Daneshjoo Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Afsaneh Doosti
Position
Audiologist
Other areas of specialty/work
Street address
Koodakiar street, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0066
Fax
Email
afsanehdoosti@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Younes Lotfi
Position
Associate Professor, Ear Nose and Throat Specialist
Other areas of specialty/work
Street address
Koodakiar street, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0100
Fax
Email
Younes1333@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Assistant professor, Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Faculty of Pharmacy, 16 Azar St. Enghelab St.
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
ahhtalasaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)