The goal of this study is evaluation of the effect of melatonin and valerian in treatment of tinitus. Seventy-eight patients with subjective idiopathic tinitus are enrolled in this study. All patients will undergo clinical examination along with recording pure tone audimeterey, speech reception threshold and speech discrimination scores . Moreover, tinitus matching test will be done in two parts (loudness and pitch). Then patients will be asked to fill out Pitsburg sleep quality and tinitus handicap inventory questionares. Subsequently, patients are randomly allocated into three groups taking different medications, half an hour before going to bed at nights during 30 days.
Group 1: melatonin; Group 2: valerian; Group 3: placebo.
After this period, tinitus matching tests will be repeated and questionnaires will be filled again for comparison and evaluating the changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011825083N3
Registration date:2016-06-10, 1395/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Farhad Farahani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 8052
Email address
farahani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Hamedan University of Medical Sciences
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Melatonin and Valerian versus Placebo in Treatment of Tinitus
Public title
Evaluation of the Effect of Melatonin and Valerian in Treatment of Tinitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Unilateral or Bilateral Tinitus in 18-65 years old patients
Exclusion criteria:Acute or chronic otitis media; Unilateral sensory neural hearing loss with abnormal MRI; Conductive hearing loss; Treatment with anticonvulsant and sedative drugs; Addiction; objective tinitus; Heart disease; Mixed hearing loss
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Ayatollah Motheri Blvd., Resalat Square
City
Hamedan
Postal code
6517838678
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.umsha.Rec.1394.141
Health conditions studied
1
Description of health condition studied
Tinitus
ICD-10 code
H93.1
ICD-10 code description
Tinitus
Primary outcomes
1
Description
tinitus
Timepoint
One month after treatment
Method of measurement
Tinitus handicap inventory questionare
Secondary outcomes
1
Description
Improvement of sleep
Timepoint
One month after treatment
Method of measurement
Pittsburgh sleep questionare
Intervention groups
1
Description
Group 1: Treatment with melatonin 3mg, 30 minutes before sleep for one month
Category
Treatment - Drugs
2
Description
group2: Treatment with valerian 320 mg,30 minutes before sleep for one month
Category
Treatment - Drugs
3
Description
Group 3: Treatment with placebo,30 minutes before sleep for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Besat Hospital
Full name of responsible person
Dr Zahra Abbasi
Street address
Ayatollah Motahari Blvd, Resalat Square
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Hamedan University Medical Sciences
Full name of responsible person
Dr Bashirian
Street address
University of Medical Sciences, Front of the Mardom Garden, Shahid Fahmide Street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Hamedan University Medical 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
Hamedan University Of Medical Sciences
Full name of responsible person
Zahra Abbasi
Position
Resident of otolaryngology and Head and Neck Surgery