In this study, we try to examine efficacy of this plant as topical analgesic on the acute migraine attack.
Method and materials: This is a Randomized, Placebo-controlled, Crossed-over Study conducted in 40 patients of the neurology Clinic of Emam Reza and Shahid Faghihi hospital, affiliated with Shiraz University of Medical Sciences,Shiraz/ Iran. The study for each patient for four attacks and a total of 120 attacks were examined.the 20 patient for initial two migraine attacks were treated with rose oil and the second two attacks with the placebo.the other 20 patient managed in the opposite order receiving the placebo for the first two attacks and rose oil for the second two attacks of migraine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511257297N2
Registration date:2015-12-12, 1394/09/21
Registration timing:na
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Mojtaba Heydari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7679
Email address
mheydari@sums.ac.ir
Recruitment status
Not enough for processing
Funding source
shiraz university of medical science
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and side effects of topical rose oil in the treatment of acute migraine headache
Public title
topical rose oil in the patients with migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with migraine headache based on 3th edition of IHS and ICHD criteria, age over 18 years, having at least 2 migraine headache every months. exclusion criteria:sensitivity to rose flowersl, pregnancy, don't sign informative testimonial, getting worse headache intensity with olphactory stimulation of drug or placebo, new diagnosed case with indication of preventive therapy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
Crossover
Other design features
basic demographic of patients, basic demographic of their headache, pain intensity of patients based on VAS before use and till 24hr after use of drug or placebo, intensity of their headache features such as nausea/vomiting,get away of light( photophobia), get away of sound with use of drug or placebo for 2hr, pain intensity in cold and hot temperament patients after use the drug or placebo
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz, Zand street, shiraz university of medical sciense
City
Shiraz
Postal code
7134845794
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.SUMS.med.REC.1394.45
Health conditions studied
1
Description of health condition studied
migraine headache
ICD-10 code
G43.0 and
ICD-10 code description
migraine without aura(common migraine) and migraine with aura(classical migraine)
essential rose oil as a drug, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period
Category
Treatment - Drugs
2
Description
Liquid paraffin as a placebo, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
neurology clinic of Namazi hospital( Emam Reza clinic)
Full name of responsible person
Maria Niazi(general practitioner)
Street address
Shiraz,Namazi square,Emam Reza clinic/Yasuj,Bahonar Blvd, 3th avenue, No 33
City
Yasuj
2
Recruitment center
Name of recruitment center
Neurology clinic of Shahid Faghihi hospital
Full name of responsible person
Maria Niazi(general practitioner)
Street address
Shiraz,Zand Street, Faghihi hospital/Yasuj,Bahonar Blvd, 3th avenue, No 33
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shiraz university of medical science
Full name of responsible person
Abdolhamid Shariat
Street address
Shiraz,zand street, shiraz university of medical science,Vice chancellor for research
City
Shiraz
Grant name
IR.SUMS
Grant code / Reference number
1394.45
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
Maria Niazi
Position
general practitioner
Other areas of specialty/work
Street address
Iran, Shiraz, Zand street,Shiraz University of Medical Science
City
Shiraz
Postal code
7134845794
Phone
+98 71 3230 5886
Fax
+98 71 3230 7809
Email
maria_niazi98@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university of medical science
Full name of responsible person
Mojtaba Heidary
Position
Assistant professor of traditional medicine
Other areas of specialty/work
Street address
Iran ,shiraz,zand street, shiraz university of medical science
City
shiraz
Postal code
7134845794
Phone
+98 71 3233 7589
Fax
+98 71 3233 7684
Email
meshkat_114@yahoo.com
Web page address
tim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
shiraz university of medical science
Full name of responsible person
Maria Niazi
Position
general practitioner
Other areas of specialty/work
Street address
Iran,Shiraz, Zand street, shiraz university of medical sciense
City
Shiraz
Postal code
7134845794
Phone
Fax
Email
maria_niazi98@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)