Investigation of the effectiveness of MigraineCut on the intensity, duration and frequency of migraine headaches of migraineurs referring to Aramesh Tehran pain clinic
Study the therapeutic effects of MigraineCut herbal drug on migraine headaches
Design
Data were collected and compared on the basis of indicators, guidelines and forms of the International Headache Society (IHS).
The medical records of patients with confirmed migraine were compiled.
Patients received the necessary training about the course of treatment, timing, medication intake, migraine markers, how to fill out daily forms.
Settings and conduct
Following the diagnosis of migraine in the study group by an expert at the Aramesh Clinic, an explanation of the treatment process and completion of the diary form and the services she/he will receive during this period will be provided.
Each month, after the necessary documentation is completed by the patient and after receiving the diary and expert consultation, the necessary medication is delivered to the patient to complete the course of treatment.
After completing the course of treatment, additional explanations were given to keep track of the treatment process and how patients were informed about the results of the study.
Participants/Inclusion and exclusion criteria
Patients with symptoms of migraine headaches were added to the study after a specialist visit and approval. If their migraine counselor reports that they have probable migraine, migraine associated with overused headaches and complex headaches, they will be excluded. Patients who drop out of treatment and do not provide adequate information to counselors are excluded from the study.
Intervention groups
The test group is a group that is undergoing treatment with MigraineCut (nasal spray). The control group is a group of patients with Migraine headaches without treatment with MigraineCut.
Main outcome variables
1- Change in the frequency 2- Change in the duration and 3- Change in the severity of the headaches. 4. Change in the clinical symptums associated with the headaches.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170705034915N3
Registration date:2019-08-23, 1398/06/01
Registration timing:registered_while_recruiting
Last update:2019-08-23, 1398/06/01
Update count:0
Registration date
2019-08-23, 1398/06/01
Registrant information
Name
Farid Semsarha
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8850 0280
Email address
fsemsarha@mimdaroo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2021-06-02, 1400/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effectiveness of MigraineCut on the intensity, duration and frequency of migraine headaches of migraineurs referring to Aramesh Tehran pain clinic
Public title
Study of the effect of MigraineCut drug on migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with migraine after being diagnosed by a neurologist.
Male or female patient has a migraine attack at least one month per year.
Patient aged between 16 and 60 years who has the opportunity to complete the diary form and communicate effectively with the counselor.
Patient that doesn't have susceptibility to herbal medicines.
Exclusion criteria:
Patient with probable migraine headaches
Patients with medication overused headaches
Patients with complex headaches
Patients who provide incomplete data and information to the counselor.
Patients who do not wish to start or continue treatment with knowledge of the conditions of the study
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
492
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of azad University-Research and science branch
Street address
Floor 13, Unit A, Central Headquarters of the Ministry of Health Education, Between South Falamak and Zarafshan, Simay Iran Avenue, Ghods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-04-17, 1398/01/28
Ethics committee reference number
IR.IAU.SRB.REC.1398.008
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headeches frequency
Timepoint
Counting the number of headaches from the beginning of the study (before the intervention), 30, 60, 90, and 120 days after the start of the MigraineCut.
Method of measurement
headache diary form
2
Description
Headache intensity
Timepoint
Record the intensity of each migraine attack every month for up to 4 months during the study.
Method of measurement
Headache diray form
3
Description
Headache duration
Timepoint
Calculate the duration of headaches before the intervention, and during 30, 60, 90, and 120 days from the onset of intervention with cutaneous migraine.
Method of measurement
Headache diray form
Secondary outcomes
1
Description
Changes in the clinical symptoms of migraineurs
Timepoint
Clinical symptoms of patients, such as sensitivity to light and sound before intervention, and 30, 60, 90, and 120 days after intervention are investigated.
Method of measurement
Headache diary form and expert visit
Intervention groups
1
Description
Migraine patients: Use of MigraineCut nasal spray containing extract of herbs intended to reduce headaches indices and clinical signs of migraine within 120 days at an authorized dose of a puff in every nasal cavity every 3 hours.
Category
Treatment - Drugs
2
Description
Control group: Migrainures group with no treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aramesh tehran pain clinic
Full name of responsible person
Nima Mosenzadeh (Neurologist)-Dr.Farid SemsarhaDr.
Street address
No. 4, 4th Street, Ganbarzadeh Street, Shahid Beheshti Street