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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
it is not clear
-
To whom data/document is available
-
it is not clear
-
Under which criteria data/document could be used
-
it is not clear
-
From where data/document is obtainable
-
Najmeh Khademolhosini
09132901996
khadem29@gmail.com
-
What processes are involved for a request to access data/document
-
it is not clear
-
Comments
-