To determine the effect of bitter almond oil on the severity of Chronic Spontaneous tinnitus
Design
A double-blind randomized, controlled clinical trial with blocked randomization phase 3 on 70 patients
Settings and conduct
This study is a double-blind 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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
The severity of tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201115049394N1
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:1
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Maryam Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 7446
Email address
m.arabi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of bitter almond oil on the severity of chronic spontaneous tinnitus, , A Double-Blind, Randomized, Clinical Trial
Public title
The effect of bitter almond oil on the severity of tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 17 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: based on Random Sequence Generator via random.org website two groups were made. Patients were allocated in one of two groups based on their entry sequence. This is a double blind study in which both researcher and patients don't know that which drug the patient have been used. Drugs will be dispensed by a third person in uniform packages with codes. Instructions on the number of consumption will not be seen by the prescriber.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, specialist and main researcher are blind. Based on block randomization table, interventions, another person except above mentioned will give medication to patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.MAZUMS.REC.1399.749
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 severity
Timepoint
Before the intervention and ending of 2th and 4th week
Method of measurement
Visual Analog Scale (VAS) for participants with tinnitus disorder
Secondary outcomes
1
Description
disability of tinnitus
Timepoint
Before the intervention, 2 and 4 weeks after the beginning of the intervention
Method of measurement
Tinnitus Handicap Inventory (THI) for participants with tinnitus disorder
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: receiving orally 25 mg Cinnarizine tablet two times a day, for one months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امیر اعلم
Full name of responsible person
Dr Assie Jokar
Street address
Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Fax
+98 21 6670 6106
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square