The effect of MigraTeb's traditional medicine on the pain of migraine and tension headaches; A randomized clinical trial
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
During 18 months, 124 patients diagnosed with migraine or tension headcases according to inclusion and exclusion criteria will be selected out of whom that are referred to Imam Reza and Farabi hospitals of Kermanshah University of Medical Sciences, then will be allocated in two same groups according to the final number of their files, the case and control groups will receive MigraTeb and placebo respectively. the patients will be evaluated for the intensity and frequency of headache 1 hour, weekly up to fourth week and analgesic consumption up to third month following intervention.
Participants/Inclusion and exclusion criteria
The inclusion criteria: the experience of headache attack twice a month. and the exclusion criteria: less than one year of headache initiation, pregnancy, malignancy, cluster headache (IHS 3), secondary headache (IHS 5-11) and cranial neuralgia (IHS 12)
Intervention groups
Intervention: MigraTeb
Case group: The patients with Migraine or tension headache who are treated by MigraTeb
Control Group: The patients with Migraine or tension headache who are treated by MigraTeb
Main outcome variables
Intensity and frequency of headache; the amount of drug consumption
General information
Reason for update
Acronym
میگرا طب و سردرد میگرن و تنشی
IRCT registration information
IRCT registration number:IRCT20081007001310N13
Registration date:2020-03-13, 1398/12/23
Registration timing:prospective
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of MigraTeb's traditional medicine on the pain of migraine and tention headaches, A randomized clinical trial
Public title
Effect of MigraTeb's on the pain of migraine and tention headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experience of headache aatack twice a month
Exclusion criteria:
History of headache less than one year
Pregnancy
Malignancy
Cluster Headache (IHS code 3)
Secondary headaches (IHS 11-5)
Cranial Neuralgia
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be divided into 2 groups according to the final number of the patient file, as if, the odds will be allocated to international group and evens in control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Following primary visit by physician and according to inclusion and exclusion criteria, the patient will be transferred to care room, the dresses will be changed then a same mask will be applied on the head for both groups of the patients as if non of patient and care giver are aware of their therapeutic group. After one hour the mask will be washed and the head will be dried and the patient will be evaluated by the physician once again.
Placebo
Used
Assignment
Parallel
Other design features
For the first time in iran , the clinical effects of the drug is evaluated
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences central Building, Beheshti Blvd, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
KUMS.REC.1398.684
Health conditions studied
1
Description of health condition studied
Migraine Headache
ICD-10 code
G43
ICD-10 code description
Migraine
2
Description of health condition studied
Tension Headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
Intensity of Headache
Timepoint
one hour, weekly up to fourth week following in intervention
Method of measurement
Patient statement
2
Description
Frequency of headache
Timepoint
weekly up to fourth week following in intervention
Method of measurement
Patient statement
3
Description
Drug consumption
Timepoint
Before and 3 months following intervention
Method of measurement
American Pain Physicians Association table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients with Migraine or tension headache will be treated by MigraTeb as a lotion which is applied on forehead and face and following one hour is washed. This lotion is a combination of Allium rotundum and Urtica dioica extract. This compound is prepared by a traditional medicine pharmacist colleague at the Kermanshah School of Pharmacy. Frequency of use is one time. After an hour, the forehead is removed.
Category
Treatment - Drugs
2
Description
Control group: The patients with Migraine or tension headache will be treated by placebo as a lotion which is applied on forehead and face and following one hour is washed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Boostan clinic, Parastar Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6326
Email
Alireza.Ahmadi@kums.ac.ir
2
Recruitment center
Name of recruitment center
Farabi Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Farabi Hospital, Isar square, Dolat abad Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3836 1046
Email
Alireza.Ahmadi@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Kermanshah University of Medical Sciences central Building, Beheshti Blvd, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 4222
Email
Alireza.Ahmadi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Alireza Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Central Building, Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
Alireza.Ahmadi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kermanshah University of Medical Sciences, Central Building, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
Alireza.Ahmadi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kermanshah University of Medical Sciences, Central Building, Beheshti Blvd, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
Alireza.Ahmadi@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available