Effect of zinc sulfate on serum lipid changes in patients with tinnitus
Design
all patients with tinnitus including organic and non organic (psychotic) will selected after clinical and microscopic examination and audiological tests and diagnosis cause of tinnitus
Settings and conduct
zinc sulfate capsule (220mg) will administrate daily for 30 days. Then, patients will clinically examine and rate of treatment will evaluate. blood sample will collect and zinc concentration and lipid level in serum will measure.
Participants/Inclusion and exclusion criteria
entrance criteria: all patients with tinnitus
exit criteria:lack of patients compliance for study continue, 2- patient under 18 and over 80 yaers
Intervention groups
receiving zinc sulfate capsule
Main outcome variables
serum concentration of zinc and lipid
General information
Reason for update
Acronym
TZL
IRCT registration information
IRCT registration number:IRCT20180624040213N1
Registration date:2018-09-16, 1397/06/25
Registration timing:registered_while_recruiting
Last update:2018-09-16, 1397/06/25
Update count:0
Registration date
2018-09-16, 1397/06/25
Registrant information
Name
Hossein Najafzadehvarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3247 6421
Email address
h.najafzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc sulfate on treatment of tinnitus and its related to lipid profile changes
Public title
Effect of zinc sulfate on treatment of tinnitus and its related to lipid profile changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with chronic tinnitus
with age 18-80 years
Exclusion criteria:
not share for study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی بابل
Street address
Babol university of medical sciences- Shahid Ghasemi sreet
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2018-07-07, 1397/04/16
Ethics committee reference number
IR.MUBABOL.REC.1397.035
Health conditions studied
1
Description of health condition studied
TINNITUS
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
effect of zinc sulfate on blood lipid changes in patients with tinnitus correction
Timepoint
before and after of intervention
Method of measurement
with commercial kit
Secondary outcomes
empty
Intervention groups
1
Description
blood sample will collect for zinc and lipids concentration from all patient with tinnitus after preamble and their satisfaction. then zinc sulfate 220 mg (in all patient from one company) will administrated for 30 days daily. patient will evaluated after 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aeatollah Rohani hospital
Full name of responsible person
Keyvan Kiakojoori
Street address
Shahid Ghasemi
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
h.najafzadeh@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Shahid Ghasemi
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghasemi
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
najafzadehvarzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghasemi
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
najafzadehvarzi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Najafzadehvarzi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghasemi
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
najafzadehvarzi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
not more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available