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General information
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According to the recommendation of the supervisor, the age of the subjects was changed in the clinical trial
According to the recommendation of the supervisor, the age of the subjects was changed in the clinical trial
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باتوجه به توصیه استاد راهنما تغییر سن افراد در کارازمایی بالینی انجام شد
باتوجه به توصیه استاد راهنما تغییر سن افراد در کارازمایی بالینی انجام شد
Recruitment centers
#1
Name of recruitment center - English: Atieh Rafsanjan Clinic
Name of recruitment center - Persian: کلنیک آتیه رفسنجان
Full name of responsible person - English: Najmeh khademolhosini
Full name of responsible person - Persian: نجمه خادم الحسینی
Street address - English: Atie building, Justice side , Zaytoun Blvd.
Street address - Persian: بلوار زیتون،جنب دادگستری،ساختمان آتیه
City - English: rafsanjan
City - Persian: رفسنجان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7719756389
Phone: +98 905 025 6218
Fax:
Email: Nazaninejalali@gmail.com
Web page address:
Name of recruitment center - English: Atieh Rafsanjan Clinic
Name of recruitment center - Persian: کلنیک آتیه رفسنجان
Full name of responsible person - English: Najmeh Khademolhosini
Full name of responsible person - Persian: نجمه خادم الحسینی
Street address - English: Atie building, Justice side, Zaytoun Blvd.
Street address - Persian: بلوار زیتون،جنب دادگستری،ساختمان آتیه
City - English: Rafsanjan
City - Persian: رفسنجان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7719756389
Phone: +98 905 025 6218
Fax:
Email: Nazaninejalali@gmail.com
Web page address:
Name of recruitment center - English: Atieh Rafsanjan Clinic Name of recruitment center - Persian: کلنیک آتیه رفسنجان Full name of responsible person - English: Najmeh khademolhosiniKhademolhosini Full name of responsible person - Persian: نجمه خادم الحسینی Street address - English: Atie building, Justice side, Zaytoun Blvd. Street address - Persian: بلوار زیتون،جنب دادگستری،ساختمان آتیه City - English: rafsanjanRafsanjan City - Persian: رفسنجان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7719756389 Phone: +98 905 025 6218 Fax: Email: Nazaninejalali@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر عابدین ایرانپور
Full name of responsible person - Persian: Dr. Abedin Iranpour
Street address - English: Faculty of Traditional Iranian Medicine, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus,Kerman
Street address - Persian: کرمان، ابتدای محور هفت باغ علوی ، پردیس دانشگاه علوم پزشکی، دانشکده طب سنتی ایرانی
City - English: kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3133 6161
Fax:
Email: khadem29@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Abedin Iranpour
Full name of responsible person - Persian: دکتر عابدین ایرانپور
Street address - English: Faculty of Traditional Iranian Medicine, Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
Street address - Persian: کرمان، ابتدای محور هفت باغ علوی ، پردیس دانشگاه علوم پزشکی، دانشکده طب سنتی ایرانی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3133 6161
Fax:
Email: khadem29@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر عابدین ایرانپورDr. Abedin Iranpour Full name of responsible person - Persian: Dr. Abedin Iranpourدکتر عابدین ایرانپور Street address - English: Faculty of Traditional Iranian Medicine, Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus,Kerman Street address - Persian: کرمان، ابتدای محور هفت باغ علوی ، پردیس دانشگاه علوم پزشکی، دانشکده طب سنتی ایرانی City - English: kermanKerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616913555 Phone: +98 34 3133 6161 Fax: Email: khadem29@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of the effectiveness of daily consumption of almond-based Iranian medicinal product on migraine headache
Design
A clinical trial with a control group, triple blinded, randomized, phase one on 80 patients, block method is used for randomization.
Settings and conduct
A triple-blind randomized clinical trial is conducted for patients referred to Atiyeh Rafsanjan Medical Clinic in 2023. The patients are divided into two groups of 40 people. One group is given propranolol and almond tablets and the other group is given propranolol and placebo, and the effects are checked in the two groups on the first day and in the 2 and 4 weeks and 2 weeks after not taking the drug. In order to blind the study, the drug and placebo are prepared by the pharmacist in uniform packages with a code and delivered to the interventionist. During the study, the patient, the researcher and the analyzer do not know about the contents of the drug package.
Participants/Inclusion and exclusion criteria
Conditions of entry: Suffering from migraine headaches with the confirmation of a neurologist; signing the informed consent form; age 15-45 years. Non-entry conditions: lactating or pregnant women; smoking and drug addiction; simultaneous use of other drugs such as anti-epileptics, benzodiazepines, barbiturates; simultaneous suffering from chronic liver, kidney, heart and other neurological diseases except migraine; unwillingness to continue cooperation; failure to follow the correct way of taking the prescribed medicine.
Intervention groups
Patients are divided into two groups of forty people. One group will be given propranolol and almond tablets and the other group will receive propranolol and placebo.
Main outcome variables
Headache severity; number of attacks; duration; Quality of Life
General information
Reason for update
According to the recommendation of the supervisor, the age of the subjects was changed in the clinical trial
Acronym
IRCT registration information
IRCT registration number:IRCT20230501058036N1
Registration date:2023-10-31, 1402/08/09
Registration timing:registered_while_recruiting
Last update:2024-05-22, 1403/03/02
Update count:1
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Najmeh Khademolhosini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 8160
Email address
khadem29@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-17, 1402/07/25
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of traditional persian medicine product based on almond on migraine: a triple-blind randomized clinical trial
Public title
Investigating the effect of traditional persian medicine product based on almond on migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from a migraine headache with the approval of a neurologist
Signing an informed consent form
Age 15 to 45 years
Exclusion criteria:
Pregnant and lactating women
Addiction to cigarettes and drugs
Simultaneous use of other drugs such as antiepileptics, benzodiazepines, barbiturates
Simultaneously suffering from chronic liver, kidney, heart and other neurological diseases except migraine
Unwillingness to continue cooperation
Failure to follow the correct way of taking the prescribed medicine
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The block method is used to randomize the two groups. In this study, quadruple blocks are used, in which two control and two interventions are considered in each block. Using the statistical software R, twenty quadruple blocks were extracted, and the arrangement of people in each block and the two intervention and control nodes are completely random.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the study, the drug and placebo are prepared by the pharmacist in packages of the same shape and with a code and delivered to the interventionist. During the study, the patient, the researcher and the analyst do not know about the contents of the drug package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Kerman Faculty of Traditional Iranian Medicine, University of Medical Sciences campus, Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.KMU.REC.1402.241
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Severity of headache
Timepoint
At the beginning of the study, 2, 4 after starting and 2 weeks after finishing the drug
Method of measurement
Visual Analogue Scale, The short Form Health Survey, Headache Impact Test-6
Secondary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study, 2-4 weeks after starting and 2 weeks after finishing the drug
Method of measurement
Visual Analogue Scale, The short Form Health Survey, Headache Impact Test-6
2
Description
Number of attacks
Timepoint
Number of attacks per week
Method of measurement
Questione
3
Description
Duration of headache
Timepoint
Number of attacks per week
Method of measurement
Question
Intervention groups
1
Description
Intervention group:The intervention group consists of 40 people and they are given propranolol and almond tablets. Propranol tablets 10 mg twice a day and almond tablets 500 mg twice a day are given for one month and on the starting day as well as in the second week and the fourth week and two weeks after not taking the drug, the effects of taking almond tablets in this group It is investigated.
Category
Treatment - Drugs
2
Description
Control group: There are forty people and they are given propranolol tablets and placebo capsules made of corn starch. Propranolol tablets 10 mg twice a day and placebo capsules twice a day are given for one month and on the first day and also in the second week and the fourth week. And two weeks after not taking the drug, the effects of taking the placebo capsule are investigated in this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Atieh Rafsanjan Clinic
Full name of responsible person
Najmeh Khademolhosini
Street address
Atie building, Justice side, Zaytoun Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719756389
Phone
+98 905 025 6218
Email
Nazaninejalali@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abedin Iranpour
Street address
Faculty of Traditional Iranian Medicine, Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6161
Email
khadem29@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoud Moghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Iranian Medicine, Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
کرمان
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6163
Email
masoudmoghaderi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazanin Jalali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Faculty of Medicine- Fars Gulf Blvd - Pistachio Blvd - University of Medical Sciences Campus - Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
37718175911
Phone
+98 343 131 500
Email
Nazaninejalali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Khademolhosini
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Iranian Medicine, Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
kerman
Province
Kerman
Postal code
7616913555
Phone
31336161
Email
khadem29@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
it is not clear
When the data will become available and for how long