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Protocol summary
To determine the effect of bitter almond oil on the severity of Chronic Spontaneous tinnitus
To determine the effect of bitter almond oil on the severity of Chronic tinnitus
To determine the effect of bitter almond oil on the severity of Chronic Spontaneous tinnitus
تعیین اثر روغن بادام تلخ بر شدت وزوز گوش مزمن خودبخودی
تعیین اثر روغن بادام تلخ بر شدت وزوز گوش مزمن
تعیین اثر روغن بادام تلخ بر شدت وزوز گوش مزمن خودبخودی
A double-blind randomized, controlled clinical trial with blocked randomization phase 3 on 70 patients
A controlled clinical trial with blocked randomization phase 3 on 70 patients
A double-blind randomized, controlled clinical trial with blocked randomization phase 3 on 70 patients
کارآزمایی بالینی دارای گروه کنترل، دو سویه کور، تصادفی شده، فاز 3 بر روی 70 بیمار و با تصادفی سازی بلوکی
کارآزمایی بالینی دارای گروه کنترل، تصادفی شده، فاز 3 بر روی 70 بیمار و با تصادفی سازی بلوکی
کارآزمایی بالینی دارای گروه کنترل، دو سویه کور، تصادفی شده، فاز 3 بر روی 70 بیمار و با تصادفی سازی بلوکی
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.
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.
This study is a double-blindcontrolled 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.
این مطالعه ازنوع کارآزمایی بالینی دو سوکور است. در این مطالعه 70 بیمار 17 تا 75 ساله با تشخیص وزوزگوش مراجعه کننده به بیمارستان امیر اعلم ، پس از اعمال شرایط ورود و خروج از مطالعه و تکمیل فرم رضایت نامه آگاهانه با بلوک بندی تصادفی در یکی از گروه های مداخله و کنترل قرار می گیرند.
این مطالعه از نوع کارآزمایی بالینی دارای گروه کنترل است. در این مطالعه 70 بیمار 17 تا 75 ساله با تشخیص وزوزگوش مراجعه کننده به بیمارستان امیر اعلم ، پس از اعمال شرایط ورود و خروج از مطالعه و تکمیل فرم رضایت نامه آگاهانه با بلوک بندی تصادفی در یکی از گروه های مداخله و کنترل قرار می گیرند.
این مطالعه ازنوعاز نوع کارآزمایی بالینی دو سوکوردارای گروه کنترل است. در این مطالعه 70 بیمار 17 تا 75 ساله با تشخیص وزوزگوش مراجعه کننده به بیمارستان امیر اعلم ، پس از اعمال شرایط ورود و خروج از مطالعه و تکمیل فرم رضایت نامه آگاهانه با بلوک بندی تصادفی در یکی از گروه های مداخله و کنترل قرار می گیرند.
گروه مداخله : قطره روغن بادام تلخ هر 12 ساعت دو قطره + قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه
گروه کنترول: قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه
گروه مداخله : قطره روغن بادام تلخ هر 12 ساعت دو قطره + قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه
گروه کنترل: قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه
گروه مداخله : قطره روغن بادام تلخ هر 12 ساعت دو قطره + قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه گروه کنترولکنترل: قرص سیناریزین 25 میلی گرم هر 12 ساعت یک عدد به مدت یک ماه
General information
Double blinded
Not blinded
doublnotbl
1
1
1
1
1
1
empty
Due to the lack of a placebo, blinding is not done and was removed in the title.
Due to the lack of a placebo, blinding is not done and was removed in the title.
empty
به دلیل نداشتن پلاسبو، کور سازی هم انجام نمیشود و در عنوان حذف شد.
به دلیل نداشتن پلاسبو، کور سازی هم انجام نمیشود و در عنوان حذف شد.
The Efficacy of bitter almond oil on the severity of chronic spontaneous tinnitus, , A Double-Blind, Randomized, Clinical Trial
The Efficacy of bitter almond oil on the severity of chronic tinnitus
The Efficacy of bitter almond oil on the severity of chronic spontaneous tinnitus, , A Double-Blind, Randomized, Clinical Trial
بررسی اثربخشی روغن بادام تلخ بر شدت وزوز گوش مزمن خودبخودی، یک کارآزمایی بالینی دو سوکور
بررسی اثربخشی روغن بادام تلخ بر شدت وزوز گوش مزمن
بررسی اثربخشی روغن بادام تلخ بر شدت وزوز گوش مزمن خودبخودی، یک کارآزمایی بالینی دو سوکور
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.
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.
Random number table: based on Random Sequence Generator via random.org website, two intervention and control groups were madecreated. 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.
با استفاده از جدول اعداد تصادفی: با استفاده از سایت random.org و استفاده از Random Sequence Generator دو گروه ساخته شد. بیمار بر اساس توالی مراجعه در یکی از این دو گروه قرار میگیرد. این مطالعه یک مطالعه دوسویه کور است ؛ به طوری که در این مطالعه فرد مورد پژوهش و پژوهشگر هر دو نسبت به داروی مصرفی بیمار بی اطلاع هستند. داروها در بسته های متحد الشکل که با کد مشخص شده توسط شخص ثالث تحویل بیمار می گردد و اطلاعات تعداد مصرف دارو توسط درمانگر قابل مشاهد نخواهد بود.
با استفاده از جدول اعداد تصادفی: با استفاده از سایت random.org و استفاده از Random Sequence Generator دو گروه مداخله و کنترل ساخته شد. بیمار بر اساس توالی مراجعه در یکی از این دو گروه قرار میگیرد.
با استفاده از جدول اعداد تصادفی: با استفاده از سایت random.org و استفاده از Random Sequence Generator دو گروه مداخله و کنترل ساخته شد. بیمار بر اساس توالی مراجعه در یکی از این دو گروه قرار میگیرد. این مطالعه یک مطالعه دوسویه کور است ؛ به طوری که در این مطالعه فرد مورد پژوهش و پژوهشگر هر دو نسبت به داروی مصرفی بیمار بی اطلاع هستند. داروها در بسته های متحد الشکل که با کد مشخص شده توسط شخص ثالث تحویل بیمار می گردد و اطلاعات تعداد مصرف دارو توسط درمانگر قابل مشاهد نخواهد بود.
Patients, specialist and main researcher are blind. Based on block randomization table, interventions, another person except above mentioned will give medication to patients.
Patients, specialist and main researcher are blind. Based on block randomization table, interventions, another person except above mentioned will give medication to patients.
بیماران و پژوهشگر اصلی و متخصصین که بیماران را ویزیت می کنند، از نوع مداخله آگاه نیستند. مداخلات، با استفاده از جدول اعداد تصادفی توسط شخصی غیر از افراد فوق الذکر به بیماران تحویل داده می شود.
بیماران و پژوهشگر اصلی و متخصصین که بیماران را ویزیت می کنند، از نوع مداخله آگاه نیستند. مداخلات، با استفاده از جدول اعداد تصادفی توسط شخصی غیر از افراد فوق الذکر به بیماران تحویل داده می شود.
Primary outcomes
#1
Visual Analog Scale (VAS) for participants with tinnitus disorder
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) for participants with tinnitus disorder
مقیاس پیوسته دیداری از افراد مبتلا به وزوز گوش
مقیاس پیوسته دیداری
مقیاس پیوسته دیداری از افراد مبتلا به وزوز گوش
Recruitment centers
#1
Name of recruitment center - English: بیمارستان امیر اعلم
Name of recruitment center - Persian: Amir Alam Hospital
Full name of responsible person - English: Dr Assie Jokar
Full name of responsible person - Persian: آسیه جوکار
Street address - English: Amir Alam Hospital
Street address - Persian: بیمارستان امیر اعلم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 6511111457
Phone: +98 21 6634 3352
Fax: +98 21 6670 6106
Email: hamiralam@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Amir Alam Hospital
Name of recruitment center - Persian: بیمارستان امیر اعلم
Full name of responsible person - English: Dr Assie Jokar
Full name of responsible person - Persian: آسیه جوکار
Street address - English: Amir Alam Hospital
Street address - Persian: بیمارستان امیر اعلم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 6511111457
Phone: +98 21 6634 3352
Fax: +98 21 6670 6106
Email: hamiralam@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان امیر اعلمAmir Alam Hospital Name of recruitment center - Persian: Amir Alam Hospitalبیمارستان امیر اعلم Full name of responsible person - English: Dr Assie Jokar Full name of responsible person - Persian: آسیه جوکار Street address - English: Amir Alam Hospital Street address - Persian: بیمارستان امیر اعلم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 6511111457 Phone: +98 21 6634 3352 Fax: +98 21 6670 6106 Email: hamiralam@sina.tums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Maryam Arabi
Full name of responsible person - Persian: مریم عربی
Position - English: Persian Medicine Student
Position - Persian: دانشجوی طب ایرانی
Latest degree: med_doctor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Street address - Persian: مرکز تحقیقات طب سنتی و مکمل دانشگاه مازندران، بلوار خزر، میدان خزر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 48168-95475
Phone: +98 11 3324 3117
Mobile: +98 912 726 5299
Fax:
Email: m.arabi@mazums.ac.i
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Maryam Arabi
Full name of responsible person - Persian: مریم عربی
Position - English: Persian Medicine Student
Position - Persian: دانشجوی طب ایرانی
Latest degree: med_doctor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Street address - Persian: مرکز تحقیقات طب سنتی و مکمل دانشگاه مازندران، بلوار خزر، میدان خزر
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 48168-95475
Phone: +98 11 3324 3117
Mobile: +98 912 726 5299
Fax:
Email: m.arabi@mazums.ac.i
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Maryam Arabi Full name of responsible person - Persian: مریم عربی Position - English: Persian Medicine Student Position - Persian: دانشجوی طب ایرانی Latest degree: med_doctor Area of specialty/work: 58 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari Street address - Persian: مرکز تحقیقات طب سنتی و مکمل دانشگاه مازندران، بلوار خزر، میدان خزر City - English: TehranSari City - Persian: تهرانساری Province: TehranMazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 48168-95475 Phone: +98 11 3324 3117 Mobile: +98 912 726 5299 Fax: Email: m.arabi@mazums.ac.i Web page address:
Protocol summary
Study aim
To determine the effect of bitter almond oil on the severity of Chronic tinnitus
Design
A controlled clinical trial with blocked randomization phase 3 on 70 patients
Settings and conduct
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.
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
Due to the lack of a placebo, blinding is not done and was removed in the title.
Acronym
IRCT registration information
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
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 tinnitus
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
No information
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 intervention and control groups were created. Patients were allocated in one of two groups based on their entry sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
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)
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
Amir Alam Hospital
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