In this study, the effect of Persian traditional medicine product that is called Sofoof Banafshe is examined on migraine headaches. According to the traditional medicine resources, Sofoofe Banafshe includes Viola Odorata, Rosa Damancena and Corianderum Sativum powder with the same amount. This study is a double blind randomized clinical trial. This reaserch is carried out at the clinic of the University of Medical Sciences on at least 86 patients with migraine. The diagnosis of migraine is confirmed by a neurologist based on the criteria of IHS (International Headache Society), and then the patients are divided into two groups. Patients in the intervention group are receiving propranolol 20 mg twice daily plus Sofoofe Banafshe capsuls 500 mg three times a day for a month, and patients in the control group are receiving propranolol 20 mg twice daily plus placebo capsules 500 mg three times a day that included starch powder for a month. Variables, duration, severity and frequency of headaches per week is evaluated in the beginning and at the end of the second week and the fourth week by using a standard questionnaire and VAS criterion. SF36 quality of life questionnaire for patients is compeleting at the same time. finally the data are analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110830776N1
Registration date:2017-03-16, 1395/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
Mohadese Kamali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2827
Email address
mohadesekamali0912@gmail.com
Recruitment status
Recruitment complete
Funding source
Assistance of Research center at Kerman University of Medical Sciences
Expected recruitment start date
2016-10-24, 1395/08/03
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional medicine product Sofoofe Banafshe on the prevention of headaches in patients with migraine
Public title
The effect of Sofoofe Banafshe on migraines
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: confirmed the diagnosis of migraine according to the criteria of IHS; 15-45 age range; patients' awareness of their disease, no pregnancy or lactation, without any other chronic diseases (heart, thyroid, hepatic, renal, neurologic, hypertension, diabetes, depression, etc.), experiencing at least four migraine attacks per month in the past few months
Exclusion criteria: dislike continuing cooperation, deciding for pregnancy or having a positive pregnancy test, experiencing non-migraine headaches; non-compliance with prescribed medication
Age
From 80 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized double-blind study using four glass blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
The Pardis of Kerman University of Medical Sciences, Haft bagh Boulevard, Kerman
City
Kerman
Postal code
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.KMU.AH.REC.1395.18
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Use additional external cause code (Chapter XX), if desired, to identify drug, if drug-induced.
Primary outcomes
1
Description
The number of migraine attacks per week
Timepoint
Two weeks and one month after intervention
Method of measurement
Self made questionnaire
2
Description
Severity of headache
Timepoint
Two weeks and one month after intervention
Method of measurement
VAS
3
Description
Freqency of headaches
Timepoint
Two weeks and one month after intervention
Method of measurement
Self made questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Two weeks and one month after intervention
Method of measurement
SF36
Intervention groups
1
Description
Patients in the control group receiving propranolol 20 mg twice daily plus placebo capsules 500 mg three times a day
Category
Treatment - Drugs
2
Description
Patients in the intervention group receiving propranolol 20 mg twice daily plus Sofoofe Banafshe capsuls 500 mg three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic 4
Full name of responsible person
Mohadese Kamali
Street address
The end of Shahid rajaee street, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Research Center of Neurology Diseases, Kerman University of Medical Sciences
Full name of responsible person
Mrs Zare
Street address
The Research Center of Neurology Diseases, Kosar Boulevard, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Research Center of Neurology Diseases, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences, School of Traditional Medicine
Full name of responsible person
Mohadese Kamali
Position
Postgraduate Persian Traditional Medicine
Other areas of specialty/work
Street address
The Pardis of Traditional Medicine, Modiriat street
City
Kerman
Postal code
Phone
+98 34 3312 2020
Fax
Email
mohadesekamali0912@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences, School of Traditional Medicine
Full name of responsible person
Mohadese Kamali
Position
Postgraduate Persian Traditional Medicine
Other areas of specialty/work
Street address
The Pardis of traditional medicine, Modiriat street
City
Kerman
Postal code
Phone
+98 34 3312 2020
Fax
Email
mohadesekamali0912@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences, School of Traditional Medicine
Full name of responsible person
Mohadese Kamali
Position
Postgraduate Traditional Medicine
Other areas of specialty/work
Street address
The Pardis of traditional medicine, Modiriat street
City
Kerman
Postal code
Phone
Fax
Email
mohadesekamali0912@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)