Determining and comparing the effectiveness of amitriptyline and melatonin on the treatment of tinnitus
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 60 patients
Settings and conduct
In this randomized double-blind clinical trial, 60 eligible patients referred to the neurology clinics of Kashani and Al-Zahra hospitals in Isfahan will be included in the study and will be randomly divided into two groups. Patients in the first group will be prescribed melatonin and in the second group amitriptyline. The intervention will be performed in such a way that the patient and the researcher will have no knowledge of the type of intervention and the double-blind conditions will be established. The severity of tinnitus will then be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age 18 to 65, diagnosis of subjective idiopathic tinnitus, and consent to participate in the study. Exclusion criteria included a diagnosis of psychiatric problems, susceptibility to tricyclic antidepressants, night shift jobs, high blood pressure, cardiovascular disease, aspirin, and salicylate compounds, hypercholesterolemia, and hyperlipidemia, and Hyperthyroidism.
Intervention groups
Intervention group 1: In this group, 3 mg melatonin tablets every night are prescribed for 6 weeks. Intervention group 2: In this group, amitriptyline 50 mg tablets are prescribed for 6 weeks.
Main outcome variables
Severity of tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N48
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-22, 1401/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the efficacy of amitriptyline and melatonin in the treatment of tinnitus
Public title
The efficacy of amitriptyline and melatonin in the treatment of tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65
Diagnosis of subjective idiopathic tinnitus
Satisfaction to participate in the study
Exclusion criteria:
Diagnosis of psychiatric problems
Sensitivity to tricyclic antidepressants
Engaging in night shift jobs
High blood pressure
Cardiovascular diseases
Consumption of aspirin and salicylate compounds
Hypercholesterolemia and hyperlipidemia
Hyperthyroidism
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 eligible patients are randomly selected. For this, the letter A is written on 30 sheets, and the letter B is written on 30 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the drugs are prepared in the same shape before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient, the patient, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-03-11, 1399/12/21
Ethics committee reference number
IR.MUI.MED.REC.1399.1148
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Severity of tinnitus
Timepoint
Before and after the intervention
Method of measurement
Tinnitus handicap inventory Questionnaire (THI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients will be prescribed 3 mg melatonin tablets (Jalinous Pharmaceutical Company) every night for 6 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, patients will be prescribed amitriptyline 50 mg tablets (Jalinous Pharmaceutical Company) every night for 6 weeks.