A phase 2 clinical trial on 60 patients,with a control group, parallel groups, double-blind, randomized design. For simple randomization random.org website will be used.
Settings and conduct
In this study, tinnitus patients who refer to RafidehHospital, Asma Comprehensive Center & Hearing Clinics & meet the inclusion criteria are included. The therapist & the patients will be blinded to the type of medicine received.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Idiopathic tinnitus, Patients over 18 years old and under 65 years old, Informed consent. Exclusion criteria:Taking anticoagulant drugs, Pregnancy or intention to become pregnant, Not feeling well, Observation of any unpredictable complications, Non-cooperation in psychoacoustic assessments, The presence of pulsating tinnitus, History of otological and neurological and Breastfeeding
Intervention groups
In this study, patients with idiopathic tinnitus with some degree of hearing loss will be randomly divided into 2 groups; Intervention group (30 people) will receive a 250 mg magnesium oxide & control group (30 people) will receive 1 placebo orally every day with the same frequency of dose & the duration of treatment will be 2 months.
Main outcome variables
Tinnitus annoyingness index; psychoacoustic level (determining the intensity of tinnitus and its annoyingness); the hearing level of the ear
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N26
Registration date:2024-10-04, 1403/07/13
Registration timing:prospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2025-07-06, 1404/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of magnesium compared to placebo in idiopathic tinnitus
Public title
The effect of magnesium in idiopathic tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic tinnitus
Patients over 18 years old and under 65 years old
Informed consent
Exclusion criteria:
Taking anticoagulant drugs
Pregnancy or intention to become pregnant
Not feeling well
Observation of any unpredictable complications
Non-cooperation in psychoacoustic assessments
The presence of pulsating tinnitus
History of otological and neurological disease
Breastfeeding
Vitamin D deficiency
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: two groups of 30 patients were created using a simple randomization method through the website www.random.org and based on the Random Sequence Generator. To hide the random allocation, the method of opaque sealed envelopes with a random sequence was used. Patients were divided into one of two groups receiving magnesium or receiving placebo based on the sequence of referrals.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind, placebo-controlled study; So that in this study, both the research subject and the therapist are unaware of the patient's medication. Medicines are delivered to the patient in uniform packages marked with a unique code by a third person, and the information about the type of medicine cannot be seen by the therapist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Pharmaceutical Sciences Unit, Islamic Azad university
Street address
No. 99, Yakhchal Ave., Gholhak, Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
19356466
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
IR.IAU.PS.REC.1403.081
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 annoyance index and psychoacoustic assessments of tinnitus
Timepoint
At the beginning of the study (before the intervention) and 60 days after starting the treatment
Method of measurement
Tinnitus Handicap Inventory (THI) questionnaire and determination of perceived loudness of tinnitus by the patient through LMT, PMT, MML
Secondary outcomes
1
Description
Hearing threshold
Timepoint
At the beginning of the study (before the intervention) and 60 days after starting the treatment
Method of measurement
Audiogram chart or ear tape
Intervention groups
1
Description
Intervention group:For people who met the criteria for entering the research, they will receive a magnesium tablet in the form of 250 mg tablet - jalinous every day for two months
Category
Treatment - Drugs
2
Description
Control group:In people who met the criteria for entering the research, they will receive a placebo in the form of oral tablets made in Islamic Azad University , every day for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafideh specialized hospital
Full name of responsible person
Seyedeh Kiana Moghaddaspour Behrouz
Street address
Shahid Nemati Alley, South Salimi Street, Andarzgoo Blvd., Qeytariyeh
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Fax
+98 21 2223 2741
Email
rofeideh.hospital@uswr.ac.ir
Web page address
https://rofeideh.uswr.ac.ir/
2
Recruitment center
Name of recruitment center
Asma comprehsive center and heenaring clinics
Full name of responsible person
Seyedeh Kiana Moghaddaspour Behrouz
Street address
Next to 20th Street, Seyed Jamaluddin Asadabadi Street, Yousef Abad
City
Tehran
Province
Tehran
Postal code
1431895531
Phone
+98 21 8848 0586
Fax
+98 21 8855 5188
Email
asma@uswr.ac.ir
Web page address
https://asma.uswr.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Yakhchal St, Shariati st.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2200 4355
Fax
+98 21 2260 2059
Email
kianamoghaddaspour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?