Determining the effectiveness of using selenium in the treatment of tinnitus
Design
This study is a clinical trial study in which patients are placed in one of the two groups treated with selenium or the control group without treatment. The sample size is 60 people for each group. Parallel groups, without blinding and phase 3 on 120 patients and randomization with random numbers table
Settings and conduct
This study will be conducted in 1402 in Al-Zahra Hospital in Isfahan on the population of tinnitus patients as a clinical trial. Patients will be randomly divided into control and case groups, and case group patients will be treated with selenium and control group patients will be treated without treatment. The researcher and the participants in this study were randomized with the help of a random number table and sealed envelopes. This study was not blinded.
Participants/Inclusion and exclusion criteria
This study is conducted on people who come with complaints of tinnitus. inclusion criteria includes patients with tinitus and without other underlying diseases
Intervention groups
In this study, patients are divided into two groups, which include the treatment group with selenium and the control group without drugs. Patients in the case group will be treated with selenium capsules 200 mg daily for 30 days, and patients in the control group will not receive any medication.
Main outcome variables
tinnitus severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230417057946N1
Registration date:2023-04-24, 1402/02/04
Registration timing:prospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Niloofar Masoomnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 0868
Email address
amnm_80@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using selenium in the treatment of tinnitus
Public title
selenium in tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years old
informed consent
Complaint of tinnitus
Exclusion criteria:
Having psychiatric and/or cognitive disorders that prevent the understanding of tests and questionnaires.
Using tinnitus-causing drugs
Having any kind of hearing loss
Patients with a history of diabetes and hypertension
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the sample size of the research, a number of letter envelopes with aluminum wrappers (in order to make the content of the envelopes unclear), preparation and each of the random sequences created with the help of a random number table are recorded on a card and the cards inside the letter envelopes are They are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of the participants, based on the order of entry into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed in such a way that if the created number is odd, the patient will be in the first group and If the number is even, the patient is placed in the second group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-30, 1402/01/10
Ethics committee reference number
IR.MUI.MED.REC.1402.045
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
tinnitus severity
Timepoint
before the study beginning and one month after one month treatment
Method of measurement
tinnitus handicap inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment with selenium. In this group, patients are treated with 200 mg of selenium daily for up to 30 days. Selenium is prescribed in the form of a supplemental tablet made in Iran, under the license of Arnet Pharmaceutical Corp of the United States, after meals once a day for up to 30 days.
Category
Treatment - Drugs
2
Description
Control group: no treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Niloofar Masomnia
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
amnm_80@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
amnm_80@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Masomnia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
amnm_80@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Masomnia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
amnm_80@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar masomnia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
amnm_80@yahoo.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