The aim of this randomized double-blind placebo-controlled, multicenter in phase2-3 clinical trial is to assess the effectiveness of licorice extract on prevention of dizziness as a side effect of propranolol in patients with migraine headache. Forty patients with migraine (age18 to 80 y/o) with systolic blood pressure lower than 120mmhg, for prophylactic management of migraine with propranolol are enrolled. Patients with hypertension or related remedies, liver, renal, adrenal and diabetic diseases, as well as pregnant participants and those sensitive to licorice are excluded. Based on the neurologist visiting, management protocol involves: 20mg propranolol two times a day plus Depakine 250 mg a day for two months and subsequently 40 mg proporanolol 2times a day plus Depakine 250 mg a day in third month. Using block randomization, patients are divided into two groups defining case (20person, licorice two green capsules three times a day) and control (20person, starch 2green capsule 3tmes a day).Each licorice’s capsule contains 350±5mg licorice extract that is equivalent with 1400±20mg root of licorice (daily dosage 2100±30mg licorice extract). Parameters (frequency and severity of dizziness, systolic and diastolic blood pressure and orthostatic hypotension) will be determined at the beginning and 3months after intervention. The study will also assess the licorice impact on the result of the management of migraine by evaluating frequency and severity of headache with migraine disability assessment test and 0-10 pain scale before and after intervention.Participants who may leave the trial will be substituted with new patients related to this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092219253N1
Registration date:2014-10-23, 1393/08/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-23, 1393/08/01
Registrant information
Name
Zahra Bahrami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3843 0456
Email address
zizi_b68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of licorice clinical effects on diziness resulting from propranolol in patients wih migraine.
Public title
Effect of licorice on management of migraine.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:40 patients with migraine (age18to80y/o)with systolic blood pressure lower than 120mmhg,for prophylactic management of migraine with propranolol are enrolled.
Exclusion criteria: patients with hypertension or related remedies, liver, renal, adrenal,diabetic diseases, as well as pregnant participants and those sensitive to licorice are excluded.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fars University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand street, in front of Palestine street, Shiraz.
City
Shiraz
Postal code
7134814336
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
CT-P-9347-4147
Health conditions studied
1
Description of health condition studied
migraine headache
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified
Primary outcomes
1
Description
frequency of headache
Timepoint
before and 3months after intervention
Method of measurement
counting
2
Description
frequency of dizziness
Timepoint
before and 3months after intervention
Method of measurement
counting
3
Description
prevalence of dizziness
Timepoint
before and 3months after intervention
Method of measurement
report of patient
4
Description
severity of dizziness
Timepoint
before and 3months after intervention
Method of measurement
numeric scale in 5level
5
Description
systolic blood pressure
Timepoint
before and 3months after intervention
Method of measurement
mmhg with mercurial manometer
6
Description
diastolic blood pressure
Timepoint
before and 3months after intervention
Method of measurement
mmhg with mercurial manometer
7
Description
orthostatic hypotension
Timepoint
before and 3months after intervention
Method of measurement
with mercurial manometer in sleeping ans standing up position after 2minutes
8
Description
severity of headache
Timepoint
before and 3months after intervention
Method of measurement
pain scale0-10
9
Description
severity of headache
Timepoint
before and 3months after intervention
Method of measurement
migraine disability assesment score test
Secondary outcomes
1
Description
serum potassium
Timepoint
6weaks after intervension
Method of measurement
sampling from patients serum,meq per liter
2
Description
weight
Timepoint
before and3months after intervension
Method of measurement
Kg with Digital weighing- machine
Intervention groups
1
Description
in cases each green capsule contains350±5miligeram extract of licorice ,it is equal with 1400±20miligeram of powder of root of licorice, that will be taken 2capsule 3times a day(at morning,noon,night) with a glass of water.as totally daily dosage will be 2100±30miligeram ectract.
Category
Treatment - Drugs
2
Description
In controls each green capsule contains 350±5miligeram starch,that will be taken 2capsules of starch 3times a day(at morning,noon,night) with a glass of water .as totally daily dosage will be 2100±30miligeram starch.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faqihi clinic
Full name of responsible person
zahra bahrami,student of medical science
Street address
Zand street, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
zahra bahrami,student of medical science
Street address
Zand street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Zahra Bahrami
Street address
Central building of Shiraz University of Medical Science, Zand street, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Zahra Bahrami
Position
student of medical science
Other areas of specialty/work
Street address
Zand street, Shiraz
City
Shiraz
Postal code
7186899411
Phone
+98 71 3843 0456
Fax
Email
zizi_b68@yahoo.combahrami.zahra1368@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Peiman Petramfar
Position
Associate professor of neurology of Shiraz University of Medical Science
Other areas of specialty/work
Street address
Pasdaran street, Shiraz.
City
Shiraz
Postal code
7186899411
Phone
+98 71 3843 0456
Fax
Email
petramfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Zahra Bahrami
Position
student of medical science
Other areas of specialty/work
Street address
Pasdaran street, Shiraz.
City
Shiraz
Postal code
7186899411
Phone
+98 71 3843 0456
Fax
+98 71 3843 0456
Email
zizi_b68@yahoo.combahrami.zahra1368@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)