Investigating the effectiveness of Ravand herbal capsule and placebo on migraine headaches
Design
This is a double-blinded clinical trial. A total of 64 patients with migraine headaches that are eligible for inclusion in the study will be selected conveniently and randomly will be assigned to intervention and control groups. Each participant will be assigned a code.
Settings and conduct
This study will be conducted as double-blind in project collaborator's office(Dr. Darius Afshari).In such a way that the main investigator and the participants in the study do not know that they are in the intervention group or in the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having more than 3 attacks per month in the last three months; Having more than 3 attacks at the base time; Migraine beginning at least one year before entering the plan; The onset of migraine before the age of 50
Exclusion criteria:Chronic tension headaches or other headaches for more than 15 days per month; Pregnancy, breastfeeding; Patients do not dependent on alcohol or other illegal substances
Intervention groups
The intervention group, in addition to the routine drug, will receive 1 of 720 mg capsule per day, prepared by Bo Ali drug company, for three months at night before bedtime with hot water.
The control group, in addition to routine drug, will receive 1 of 720 mg placebo capsule per day for three nights before bedtime with hot water.
Main outcome variables
Headache severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150824023742N1
Registration date:2017-12-26, 1396/10/05
Registration timing:prospective
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 2052
Email address
mrezaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness and non-effectiveness of Ravand herbal capsule and Placebo on migraine headaches
Public title
Investigating the effectiveness of Ravand herbal capsule on migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having more than 3 attacks per month in the last three months
Having more than 3 attacks at the base time
Migraine begining at least one year before entering the plan
The onset of migraine before the age of 50
Exclusion criteria:
Chronic tension headaches or other headaches for more than 15 days per month
Pregnancy, breastfeeding
Patients do not dependent on alcohol or other illegal substances
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be performed with 4 blocks. One of the project partners carries out the randomization plan and writes codes for people on a sheet and this sheet remains with him or her until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and participants have been blinded to this study. There is no information about assigning people to groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
بلوار شهید بهشتی، ساختمان شماره 2، دانشگاه علوم پزشکی، معاونت تحقیقات و فناوری
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
kums.rec.1396.434
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G98
ICD-10 code description
Nervous system disorder NOS
Primary outcomes
1
Description
Headache severity
Timepoint
At the beginning of the study, one month after the beginning of the study and the end of the study
Method of measurement
Base on Migraine Disability Assessment (MIDAS) and Headache Impact Test(HIT6)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to the routine drug, will receive 1 of 720 mg capsule per day, prepared by Bo Ali drug company, for three months at night before bedtime with hot water
Category
Treatment - Drugs
2
Description
The control group, in addition to routine drug, will receive 1 of 720 mg placebo capsule per day for three nights before bedtime with hot water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Afshari's office
Full name of responsible person
Dr. Daryoush Afshari
Street address
Shariati Ave. Dr. Afshari's office
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3727 8025
Email
afshari_d@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Fakhri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Isar Square, Dolatabad Blvd, School of Public Health
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Email
n.fakhri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mansour rezaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Isar Square, Dolatabad Blvd, School of Public Health
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Fax
Email
mrezaei@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Fakhri
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Isar Square, Dolatabad Blvd, School of Public Health
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4447
Email
n.fakhri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
En The main outcomes of the study will be shared.
When the data will become available and for how long
4months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Researchers who have a similar study and found contradictory results that are not logical
From where data/document is obtainable
En To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a10-day period, the documents will be sent e-mail