History
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Registration date |
Revision Id |
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12
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2025-04-23, 1404/02/03 |
338187
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11
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2025-03-28, 1404/01/08 |
334814
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10
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2025-02-21, 1403/12/03 |
331480
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9
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2025-01-17, 1403/10/28 |
328746
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8
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2024-12-20, 1403/09/30 |
325661
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7
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2024-11-23, 1403/09/03 |
322107
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6
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2024-10-25, 1403/08/04 |
319125
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5
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2024-09-27, 1403/07/06 |
316246
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4
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2024-08-23, 1403/06/02 |
312918
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3
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2024-07-26, 1403/05/05 |
309351
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2
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2024-06-21, 1403/04/01 |
305935
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1
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2024-05-17, 1403/02/28 |
302032
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Protocol summary
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Study aim
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Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 2024
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Design
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A double-blind randomized clinical trial with a control group, with 3 parallel groups, phase 3 on 120 patients, randomization using shuffling cards.The study conducts in 1403
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Settings and conduct
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The study was conducted in loghman Hospital in 2024 in eligible patients with idiopathic tinnitus. After randomizing the patients by shuffling cards, the patients are divided in 3 groups of lidocaine, dexamethasone and saline injection. The audiogram and the tinnitus handicap inventory are completed and the injections are done 4 times during 2 weeks (2 injections every week with an interval of 3 days) under the microscope and the results are evaluated.
injections are done by doctor.
In this study, blinding of the participant and the clinical caregiver is done, and they don't know the type of injectable substance.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with tinnitus referred to loghman Hospital in 2024; patients whose tinnitus cause cannot be found; patients who don't have concomitant ear disorders.
Exclusion criteria: patients who exit the study for any reason during the research; patients who don't complete study follow up.
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Intervention groups
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The study consists of 3 groups of 40 people
In each 3 groups, injections are done 4 times during 2 weeks (2 injections every week with an interval of 3 days) under the microscope.
First group: intratympanic injection of dexamethasone.
Second group: intratympanic injection of lidocaine
third group: intratympanic injection of saline
The first and second groups are intervention groups and the third group is control group.
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Main outcome variables
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Tinnitus reduction; complications: hearing loss؛ tympanic membrane perforation؛ dizziness
General information
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Reason for update
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Due to the increase in accuracy and lack of bias in the results, the study is conducted in a triple-blinded manner.
The start date of patient entry was entered (June 26, 2024)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240420061531N1
Registration date:
2024-05-17, 1403/02/28
Registration timing:
prospective
Last update:
2024-07-27, 1403/05/06
Update count:
11
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Registration date
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2024-05-17, 1403/02/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-05-21, 1403/03/01
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Expected recruitment end date
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2024-12-21, 1403/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 1403
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Public title
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Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with tinnitus referred to Luqman educational-therapeutic-research center in 2024
Patients who cannot find a cause for their tinnitus
Patients who include tinnitus and without concomitant disease such as rupture of the eardrum, a history of ear surgery, otosclerosis, Cerebellopontine angle tumor, ear trauma, disorders of internal systems such as hypothyroidism,Monocular hearing, diabetes and genetic disorders.
Exclusion criteria:
Patients who are excluded from the study for any reason during the research or follow-up is not possible.
Patients who do not complete the full follow-up of the study (follow-up within 3 months).
Patients who are excluded from the study due to possible complications.
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Age
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No age limit
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In general, simple randomization of people by the method of shuffling cards
+ Description of the randomization process:
The process of generating a random sequence will be done in the form of simple randomization and through the preparation and shuffling of cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by removing them, a card is taken out and its allocation is recorded, and that card is returned to the other cards. Then the cards are dealt again and so on
Another card is taken out. This process will continue until reaching a random sequence according to the sample size.
Concealment of random allocation will be done by placing the mentioned cards inside sealed opaque envelopes. People from the research team who are responsible for the above steps enter other steps
The research, especially the examination and analysis of people in terms of the dependent variable, will not be done (for blinding).
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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To blind the participants, the method of flipping cards is used. Patients choose from sealed cards and enter one of 3 intratympanic injection categories.
Also, the people who are responsible for intratympanic injection (clinical caregivers) only perform intratympanic injection and do not know the nature of the injected substance.
Also, the researchers who are in charge of analyzing and completing the tinnitus forms and questionnaire are also not aware of the type of injectable substance.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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The side effects of intratympanic injection, which is one of the limiting factors of this method, are carefully examined. For example, in recent studies, lidocaine injection has a low but significant effect, but its use is limited due to severe vertigo.
Ethics committees
1
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Ethics committee
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Approval date
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2024-04-09, 1403/01/21
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Ethics committee reference number
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IR.SBMU.MSP.REC.1403.018
Health conditions studied
1
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Description of health condition studied
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Tinnitus
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ICD-10 code
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H93.19
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ICD-10 code description
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Tinnitus, unspecified ear
Primary outcomes
1
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Description
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Tinnitus reduction in tinnitus handicap inventory (6 to 8 marks)
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Timepoint
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In the period of the first 2 weeks after the injections and 1 month and 3 months later. First, before the start of the injections, at the beginning of the study, then at the end of 2 weeks, 1 month and 3 months. It is measured 4 times overall.
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Method of measurement
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THI (tinnitus handicap inventory) questionnaire to measure tinnitus. Tinnitus handicap inventory is a 25-item questionnaire to determine the severity of tinnitus disability, which psychometrics have been proven in studies. The 25 items of the questionnaire are classified into three functional, emotional and catastrophic subscales.
Secondary outcomes
1
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Description
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Tympanic membrane perforation
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Timepoint
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In the first 2 weeks and 3 months later. It is checked twice in the study
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Method of measurement
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Examination under the microscope
2
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Description
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Hearing loss
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Timepoint
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In the first 2 weeks and 3 months later. It is checked twice in the study
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Method of measurement
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Audiogram
Intervention groups
1
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Description
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intervention group: intratympanic injection of dexamethasone. In the first intervention group, which is a group of 40 people, they are subjected to intratympanic injection of dexamethasone 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material.The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the postero-inferior area of the tympanic membrane (near the round window). Dexamethasone is manufactured by IranHormon Pharmaceutical Company, which contains 8 mg of dexamethasone in 2 cc vials. The injection volume is 1 cc per session which is equivalent to 4 mg of dexamethasone (the middle ear volume in an adult human is an average 0.5 to 1 cc)
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Category
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Treatment - Drugs
2
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Description
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Intervention group: intratympanic injection of lidocaine. In the second intervention group, which also includes a group of 40 people, intratympanic injection of lidocaine was performed 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material.The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the posterior lower area of the eardrum (near the round window). Lidocaine is manufactured by IranHormon Pharmaceutical Company, which contains 5 cc vials containing 100 mg of lidocaine. The injection volume is 1 cc per session, which is equivalent to 20 mg of lidocaine (the middle ear space in an adult human is on average 0.5 to 1 cc)
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Category
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Treatment - Drugs
3
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Description
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Control group: intratympanic injection of saline. In the third group, which is the control group of the study, there are also 40 people and intratympanic injection of sterile saline is done 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material. The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the posterior lower area of the eardrum (near the round valve). The injection volume is 1 cc of sterile saline per session (the middle ear space in an adult human is on average 0.5 to 1 cc)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The data related to people is most likely to be published after anonymizing them with details related to variables, etc
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When the data will become available and for how long
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After the end of the study and review and analysis of the data and the publication of the study, which will probably be in the middle of 1404
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To whom data/document is available
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Academic and scientific institutions
Other people's access is not allowed
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Under which criteria data/document could be used
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For use in the treatment of patients and analysis to draw conclusions about the effect of drug injections
Comparing the effects of 3 types of injected substances and checking variables such as age and sex, duration of tinnitus onset, etc. is allowed
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From where data/document is obtainable
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to the research assistant of Shahid Beheshti University of Medical Sciences
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What processes are involved for a request to access data/document
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After the verification of the scientific degree of the person or the organization by the university, the information is provided to the person or the organization
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Comments
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