The study of effectiveness of systemic Magnesium in treatment of sudden sensory neural hearing loss versus placebo in patient referred to ear nose and throat clinic of Taleqani hospital.
Evaluation of the effect of oral magnesium in the treatment of sudden sensorineural hearing loss
Design
Clinical trial with parallel intervention and control groups is performed in the two blind side of randomized blocks on 64 patients.
Settings and conduct
Patients are divided into intervention and control groups based on blocked randomization and given to participants the drug or placebo and the results are evaluated based on audiometry at the end of 2 weeks and end of the month
Participants/Inclusion and exclusion criteria
Patients with sudden sensory neural hearing loss without unestablished reason that have been identified for up to 15 days after the onset of the disease and have not received treatment and have been referred or referred to the ENT clinic of Taleghani Hospital.
Intervention groups
Intervention: in this study, the intervention group is given standard treatment of the disease and oral magnesium.
The control group is given standard treatment and placebo.
Main outcome variables
Average hearing threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200430047245N1
Registration date:2021-05-23, 1400/03/02
Registration timing:registered_while_recruiting
Last update:2021-05-23, 1400/03/02
Update count:0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Mohamad Taha Mehdi Araghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 3960
Email address
tahamehdiaraghi1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-24, 1400/02/04
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effectiveness of systemic Magnesium in treatment of sudden sensory neural hearing loss versus placebo in patient referred to ear nose and throat clinic of Taleqani hospital.
Public title
The study of effectiveness of systemic Magnesium in treatment of sudden sensory neural hearing loss versus placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Affection to sudden sensory neural hearing loss
The reason of sudden sensory neural hearing loss be idiopathic
Exclusion criteria:
Referral after 1 month from the onset of the disease
Contraindications to oral corticosteroids such as diabetes, hypertension, gastric ulcer or duodenum
Evidence of systemic infectious or inflammatory diseases
Coagulation disorders
Other known causes of sudden sensory neural hearing loss
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization.
According to the number of 64 samples in the randomization method, 8 blocks with 8 parts with the identifiers A, B, C, D, E, F, G, H are created, which We put in 4 of them drugs and the other 4 placebos with complete physical characteristics.
The blocks are placed in the clinic after made them.And participants in the project are given a part of a block and patient information and number and part of the block will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind study.
Due to the blocked randomization method, the participant and the researcher are blinded to the content of each block component.And participants do not know the content of the received block. And the researcher only records the patient information and the number and part of the delivered block and remains blind to the contents of the block throughout the treatment and study course.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Research Ethics Committee, School of Medicine, next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.SBMU.MSP.REC.1399.717
Health conditions studied
1
Description of health condition studied
Sudden sensory nueral hearing loss
ICD-10 code
H91.2
ICD-10 code description
Sudden idiopathic hearing loss
Primary outcomes
1
Description
Average hearing threshold
Timepoint
Mean hearing threshold before the start of the study and 14 days after the intervention and the end of the month
Method of measurement
Audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients with sensorineural hearing loss undergo standard treatment with oral corticosteroids at a dose of 1 mg per kg body weight per day with 50 mg tablets of Iran hormon company and 250 mg magnesium oxide by Galinus company daily for 14 days. The treatment process is assesed by audiometry in Taleghani Hospital audiometry center, before the start of treatment and at the end of the 14th day of treatment and the end of 1 month.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients are treated with standard treatment with prednisolone with 50 mg tablets of Iran Hormone Company at a dose of 1 mg per kg body weight and microcrystalline cellulose placebo one tablet per day with a completely similar appearance to the main drug for 14 days .And the treatment process is assesd by performing audiometry in the audiometry center of Taleghani Hospital at the beginning of treatment and on the 14th day of treatment and at the end of 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani hospital Ent clinic
Full name of responsible person
Mohamad Taha mehdi araghi
Street address
Taleghani Hospital, next to Shahid Beheshti University of Medical Sciences, Erabi St., Yemen St., Shahid Chamran Highway