Protocol summary
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Study aim
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To determine the effect of bitter almond oil on the severity of Chronic tinnitus
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Design
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A controlled clinical trial with blocked randomization phase 3 on 70 patients
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Settings and conduct
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This study is a controlled clinical trial . In this study, 70 patients aged 17 to 75 years with a diagnosis of tinnitus referred to Amir Alam Hospital, after applying the conditions of entry and exit from the study and completing the informed consent form with random blocking are placed in one of the intervention and control groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with chronic tinnitus with doctor confirmation 17 to 75 years old male and female have tendency for entering into study. Exclusion criteria: Pregnancy & breast-feeding, brain surgery, cancer ,Meniere's syndrome ,Pulsatile tinnitus , ear surgery, temporomandibular joint disorders, eardrum rupture, severe vocal trauma, chronic middle and outer ear infection.
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Intervention groups
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Intervention group: two drops of bitter almond oil every 12 hours + cinnarizine 25 mg tablet every 12 hours for one month
Control group: cinnarizine 25 mg tablet every 12 hours for one month
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Main outcome variables
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The severity of tinnitus
General information
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Reason for update
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Due to the lack of a placebo, blinding is not done and was removed in the title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201115049394N1
Registration date:
2021-02-16, 1399/11/28
Registration timing:
prospective
Last update:
2021-03-01, 1399/12/11
Update count:
1
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Registration date
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2021-02-16, 1399/11/28
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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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2021-03-05, 1399/12/15
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Expected recruitment end date
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2021-08-11, 1400/05/20
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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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The Efficacy of bitter almond oil on the severity of chronic tinnitus
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Public title
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The effect of bitter almond oil on the severity of 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 chronic tinnitus with doctor confirmation
17 to 75 years old
Male and female
Have tendency for entering into study
Exclusion criteria:
Pregnancy & breast-feeding
Brain surgery
Cancer
Meniere's syndrome
Pulsatile tinnitus
Ear surgery
Temporomandibular joint disorders
Eardrum rupture
Severe vocal trauma
chronic middle and outer ear infection
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Age
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From 17 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random number table: based on Random Sequence Generator via random.org website, two intervention and control groups were created. Patients were allocated in one of two groups based on their entry sequence.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-11, 1399/07/20
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Ethics committee reference number
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IR.MAZUMS.REC.1399.749
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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H93.1
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ICD-10 code description
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Tinnitus
Primary outcomes
1
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Description
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Tinnitus severity
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Timepoint
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Before the intervention and ending of 2th and 4th week
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Method of measurement
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Visual Analog Scale (VAS)
Secondary outcomes
1
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Description
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disability of tinnitus
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Timepoint
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Before the intervention, 2 and 4 weeks after the beginning of the intervention
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Method of measurement
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Tinnitus Handicap Inventory (THI) for participants with tinnitus disorder
Intervention groups
1
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Description
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Intervention group:: receiving Bitter Almond ear drops with the licence of Medical Equipment Department by Barig Essence Company, two times a day, each time 2 drops and 25 mg Cinnarizine tablet two times a day for one months.
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Category
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Treatment - Drugs
2
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Description
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Control group: receiving orally 25 mg Cinnarizine tablet two times a day, for one months.
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Category
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Treatment - Drugs
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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Mazandaran University of Medical Sciences
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Proportion provided by this source
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70
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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available