This study is a double blind randomized clinical trial to examine the effect of topical products containing rose oil to treat migraines. 90 patients 20 to 50 years old( Swithout any underlying medical condition such as diabetes, hypertension, cardiovascular, liver, kidney, gynecology, gastrointestinal diseases, allergies and other neuorologic disorders ) with migraine without aura of Hospital Lukman Hakim in Tehran after obtaining moral satisfaction will be divided in two groups (intervention/control) and improvement of clinical symptoms include reducing the severity, frequency, duration and associated symptoms of migraine attacks and side effects will be assessed at intervals of 1 week, 2 weeks and 1 month after initiation of treatment by questionnaire.. Patients who have more than 15 days per month with headaches will be included.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071318462N1
Registration date:2016-08-30, 1395/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Bita Ebadollahzadeh Haghani
Name of organization / entity
Faculty of Traditional Medicine, Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
haghanib891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-28, 1395/06/07
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
Evaluation the Effect of Topical Product Containing Rosa Damascena Oil in Migraine Treatment
Public title
Effect of Roa Damascena oil on migrain headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: between 20-50 years; patient with migraine without aura; at least 1 year after the onset of illness; voluntary consent of the patient
Exclusion criteria: have a headache more than 15 days per month; Any disorder or disability of mind that their cooperation with corrupted; Incorrect use of the drug; any history of allergies; an underlying medical condition such as diabetes, hypertension, heart disease, organs and peripheral vascular problems,liver disease, kidney, gastrointestinal, gynecological and neurological diseases than any migraines; an allergy or skin irritation and other side effects possible during the intervention; no response to treatment and need to complete treatment or extreme;n ot referring to control symptoms Ckech complete list
Age
From 20 years old to 50 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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
research/930599/1/369
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Clinical status improvement
Timepoint
before intervention/1 week later/2 week later/1 months later
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Any side effect of drug
Timepoint
1 week/2 week/1 month after taking medication
Method of measurement
quesionnaire
Intervention groups
1
Description
Intervention group:Rosa Damascena oil
1 cc right temporal region/1 cc frontal/1 cc left temporal region
duration:1 month
massage on skin for 1 minute
Category
Treatment - Drugs
2
Description
Control group:paraffin
1 cc right temporal region/1 cc frontal/1 cc left temporal region
duration:1 month
massage on skin for 1 minute
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hospital in Tehran
Full name of responsible person
Bita Ebadollahzadeh Haghani
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Said Islame
Street address
Ghoreish Building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mashhad 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
Faculty of Traditional Medicine
Full name of responsible person
Bita Ebadollahzadeh Haghani
Position
Physician, PhD student
Other areas of specialty/work
Street address
opposite the Mehran Stadium, 6th Jahad, Jahad St.,
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
haghanib891@mums.ac.ir, bita5110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Traditional Medicine, Mashhad University of Medical Science
Full name of responsible person
Dr Mandana Tavakkoli kakhaki
Position
Dr
Other areas of specialty/work
Street address
Faculty of Traditional Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
Tavakkolimk@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
Bita Ebadollahzadeh Haghani
Position
Physician, PhD student
Other areas of specialty/work
Street address
opposite the Mehran Stadium, 6th Jahad, Jahad St.,
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
haghanib891@mums.ac.ir, bita5110@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)