Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches: A randomized, double blind, placebo controlled trial
Evaluation of the effects of Iraj Fiqra herbal pills in the treatment of migraine
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. For randomization, we will use the restricted randomization method of block randomization.
Settings and conduct
Setting: Physician Office. Intervention: Eligible patients are randomly assigned to two groups of standard migraine treatment with placebo or standard treatment with Iarj fiqra. Eligible patients receive routine migraine treatment with one Iraj Fiqra pill and the other group receive routine treatments with placebo tablets. The MIDAS (migraine disability assessment) questionnaire will be completed at the beginning of the study and two months later, the HIT-6 questionnaire (headache impact test -6) at the beginning of the first and second months of the study.
Participants/Inclusion and exclusion criteria
Patients with migraine without aura will be included in the study. Patients will be excluded from the study if they have chronic headache, pregnancy and lactation, the presence of some underlying disease and the concomitant use of certain medications, use of migraine prevention medication, drug or alcohol abuse and patient dissatisfaction.
Intervention groups
Eligible patients receive regular migraine treatment with a 500 mg Iraj Fiqra tablet for two months. The control group receives the usual treatments along with placebo pills
Main outcome variables
The primary outcome will include the evaluation of the number, severity, and duration of migraine attacks.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081208001497N9
Registration date:2021-08-20, 1400/05/29
Registration timing:prospective
Last update:2021-08-20, 1400/05/29
Update count:0
Registration date
2021-08-20, 1400/05/29
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches: A randomized, double blind, placebo controlled trial
Public title
Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having migraine without aura (according to the criteria of the International Headache Association (HIS), which is diagnosed by the physician
Age between 18 and 65
History of migraine of at least one year
The first migraine attack at the age of less than fifty years
Have at least three attacks per month in the last three months
Having a score higher than 6 according to the MIDAS questionnaire
Exclusion criteria:
Having headaches between two migraine attacks that are indistinguishable from migraine attacks
Chronic tension headache or other types of headache for more than 15 days a month
Pregnancy and lactation
The presence of underlying heart problems such as arrhythmias
History of biliary problems
Comorbidities with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease
History of hemorrhoids
Concomitant use of sedatives such as phenobarbital
Concomitant use of diuretics, oral corticosteroids
Concomitant use of laxatives such as polyethylene glycol or magnesium hydroxide
Daily consumption of migraine prophylaxis for the past month
Take at least three migraine medications for prophylaxis over the past ten years
Drug or alcohol abuse
Patient dissatisfaction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomized by random blocking method with blocks of 4 which generated by Random Allocation software version 2. Blocking and allocation sequence for concealment will be done by the person not involved in the research (Allocation Concealment). The sample allocation ratio will be (1: 1 Allocation) and will be divided into two groups of drug recipients and placebo (Assignment). Drugs will then be given to patients based on the blocks obtained and in the order of allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be performed as double-blind. The drug and placebo packing package and code allocation is done by the researcher involved in the research and then provided to the main researcher. In this way, the physician and patients will not know the contents of the packages and the type of codes and will not know which of the two control or test groups it belongs to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.162
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
Primary outcomes
1
Description
Evaluation of the number of migraine attacks
Timepoint
Upon arrival, first and second month
Method of measurement
MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6)
2
Description
Evaluation of the severity of migraine attacks
Timepoint
Upon arrival, first and second month
Method of measurement
MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6)
3
Description
Evaluation of the duration of migraine attacks
Timepoint
Upon arrival, first and second month
Method of measurement
MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Eligible patients receive regular migraine treatment with a 500 mg tablet of Iaraj Fiqra (NIAK Pharmaceutical Company) for two months. Common medications include triptans, ergotamine derivatives, analgesics like NSAIDs, acetaminophen, and anti-emetic drugs such as metoclopramide and corticosteroids.
Category
Treatment - Drugs
2
Description
Control group: They receive the usual treatments along with placebo pills. This pill is prepared by NIAK Pharmaceutical Company and contains exponents such as lactose and magnesium stearate without active ingredient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physician office
Full name of responsible person
Dr Fariborz Khorvash
Street address
Qasr Crossroads - Rudaki Building
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research deputy of Isfahan University of Medical Sciences
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Grant name
Grant code / Reference number
54710
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Fax
+98 31 3668 0011
Email
s.mousavi@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Fax
+98 31 3668 0011
Email
s.mousavi@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Fax
+98 31 3668 0011
Email
s.mousavi@pharm.mui.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Published article
When the data will become available and for how long
One year
To whom data/document is available
All people
Under which criteria data/document could be used
No condition
From where data/document is obtainable
Scientific responded of the study
What processes are involved for a request to access data/document