1- Determining and comparing the frequency of the number of attacks between the two groups receiving venlafaxine and amitriptyline before and 8 weeks after treatment
2- Determining and comparing the average length of attacks between the two groups receiving venlafaxine and amitriptyline before and 8 weeks after treatment.
3- Determining and comparing the severity of attacks between the two groups receiving venlafaxine and amitriptyline before and 8 weeks after treatment
4- Determining the demographic characteristics (age, sex, and duration of the disease) between the two groups receiving venlafaxine and amitriptyline
Design
Any patient who has been diagnosed with migraines and is eligible for admission will randomly receive one of the two drugs, amitriptyline 25 or venlafaxine 37.5, for 60 days in two 30-day intervals.
Settings and conduct
Migrainous patients will receive one of two drugs, amitriptyline or venlafaxine. While using the drugs, they will fill in the relevant questionnaire and the details of their attacks will be collected.
Participants/Inclusion and exclusion criteria
Entry Conditions: People with migraines, people who experience at least three attacks a month, people who have never used two drugs, amitriptyline, and venlafaxine, to manage their attacks.
Persons
Failure to enter: Pregnant women or women who are planning to become pregnant within the next two months.
People with a history of seizures or specific cardiovascular or cerebral surgery. Patients with glaucoma, benign prostatic hyperplasia, or high blood pressure.
Intervention groups
Intervention group: Patients who will receive venlafaxine at a dose of 37.5 once a day for 8 weeks.
Control group: Patients receiving amitriptyline at a dose of 25 daily for 8 weeks.
Main outcome variables
Number, severity, and duration of attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170814035697N6
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Hamdolah Sharifi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4992
Email address
sharifi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study of Preventive Effects of Venlafaxine with Amitriptyline in Migrainous Patients
Public title
Effects of venlafaxine and amitriptyline on migraines
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with migraine
People who experience 3 or more attacks each month
People who have never used amitriptyline or venlafaxine to manage their attacks
Exclusion criteria:
People who are pregnant or planning to become pregnant in the next two months
People with a history of specific cardiovascular or cerebral surgery
People with a history of seizures
People with high blood pressure
people with Benign prostatic hyperplasia
People with glaucoma
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Both drugs are in the same package. 40 packs of Venlafaxine 37.5 will be in a box called V and 40 packs of amitriptyline 25 will be in a box called A. 40 cards with the letter A and 40 cards with the letter V will be placed in a box. For each patient who is eligible to receive both drugs after the examination, one of the cards is accidentally taken out of the box and one of the two drugs venlafaxine or amitriptyline is given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the project, researcher, and mentor will be blind to the drug used by patients. But the doctor will be informed about the medication. The medicines will be packed in similar envelopes and placed in two boxes with the signs that only the doctor will know about. Patients are first told that they will take one of the two drugs venlafaxine 37.5 or amitriptyline 25 randomly (e.g., first patient, amitriptyline, and second patient, venlafaxine, and so on), but depending on which drug they will consume, will be unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat Ave; Jahad Blvd; Urmia; West Azerbijan Provine; Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.UMSU.REC.1399.089
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
incidence of Headache
Timepoint
At the beginning of the study and two months after the start of the study
Method of measurement
The six-item Headache Impact Test. Headache Impact Test is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.Your score shows you the effect that headaches have on normal daily life and your ability to function. Headache Impact Test was developed by an international team of headache experts from neurology and primary care medicine in collaboration with the psycho metricians who developed the SF-36®health assessment tool. This questionnaire was designed to help you describe and communicate the way you feel and what you can not do because of headaches.
Secondary outcomes
1
Description
severity of attacks
Timepoint
At the beginning of the study and two months after the start of the study
Method of measurement
The six-item Headache Impact Test
2
Description
duration of attacks
Timepoint
At the beginning of the study and two months after the start of the study
Method of measurement
The six-item Headache Impact Test
3
Description
number of attacks
Timepoint
At the beginning of the study and two months after the start of the study
Method of measurement
The six-item Headache Impact Test
Intervention groups
1
Description
Intervention group: venlafaxine taking group. Intervention in this group: Patients will take one venlafaxine tablet with a dose of 37.5 per day made by Sami Saz Pharmaceutical Company for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: amitriptyline taking group. Intervention in this group: Patients will take one amitriptyline tablet with a dose of 25 per day made by Iran Daru Pharmaceutical Company for 8 weeks.