Protocol summary

Study aim
Determination of the effect of Basil on the severity of headache and the frequency of recurrence of headache attacks (the number of migraine attacks over a period of six months) in migraine headache patients
Design
The clinical trial has four types of experimental and control group, each of which is 36, is community based and pragmatic, with parallel groups, blind, randomized
Settings and conduct
Diagnosis was performed by a neurologist at a specialized clinic Rahimi Hospital (Khorramabad-Iran). Essential oil extraction method of Basil plant, in the form of water extraction by water distillation. In all groups, routine treatment, which prescribed acetaminophen 325 for all groups, and only Acetaminophen 325, and other groups, were treated with Acetaminophen with different doses of essential oil of the Basal plant. Basil essential oil was prepared with doses of 2,4,6% and was provided to the patient for topical use on the forehead and every eight hours.
Participants/Inclusion and exclusion criteria
The study population of men and women with migraine headache referring to the Neurology Clinic of Rahimi Hospital (Khorramabad-Iran). In the period from the beginning of the second half of 2013 for a year The upper age limit of 18 years
Intervention groups
Three groups of 36 patients in the experimental group received doses of 2, 4 and 6% of Basilicum and one group of 36, as the control group with 250 doses of Acetaminophen, with the composition of essential oil without the Basilic acid substance in the intervention groups. The experimental group was visited at the specified time intervals (second week, fourth week, second month, third month) by referring to the neurologist and according to designed questionnaires, the relapse rate and headache severity were measured.
Main outcome variables
Severity of pain and number of migraine attacks

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130825014472N3
Registration date: 2018-07-31, 1397/05/09
Registration timing: retrospective

Last update: 2018-07-31, 1397/05/09
Update count: 0
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Parviz Bahrami
Name of organization / entity
Raziherbal Medicine Center
Country
Iran (Islamic Republic of)
Phone
+98 66 1320 0103
Email address
bahrami.p@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Raziherbal Medicine Center
Expected recruitment start date
2013-10-12, 1392/07/20
Expected recruitment end date
2014-11-11, 1393/08/20
Actual recruitment start date
2013-12-06, 1392/09/15
Actual recruitment end date
2015-12-30, 1394/10/09
Trial completion date
empty
Scientific title
The effect of Ocimum Basilicium oil on pain and headache in patient who has migraine
Public title
The effect of Ocimum Basilicium on cure Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The study population of men and women with migraine headache referring to the Rahimi hospital clinic (Khorramabad-Iran) In the period from the beginning of the second half of 2013 for a year The upper age limit of 18 years
Exclusion criteria:
Patients who have consumed oral medications - other topical medications during the past 1 month
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 146
Actual sample size reached: 145
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will achieve with using sample block method.The studied units will be assigned to the four groups according to the criteria for inclusion in the study and available on the basis of randomized blocking. The entry of individuals to each of the groups will be done in the order of the number of selected blocks and will be done using the layout inside the block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Considering that one of the response variables (severity of pain) is highly dependent on the induction effects, the study is a three-point study. Also, to eliminate the effects of induction, an ophthalmic drug was used in the control group. In case of using the patient with other drugs, the patient was asked to complete the list of all used medications in the relevant form. To evaluate the outcome of the safety organization, no information was given on the dosage of medications and the expected results, so that the conditions could be genuinely evaluated.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2013-11-22, 1392/09/01
Ethics committee reference number
200/96196

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura

Primary outcomes

1

Description
Severe headache
Timepoint
Before and after engaging in the second and fourth week , the second month, third month and sixth month
Method of measurement
VAS scale, Questionnaire bak, Examination physice

2

Description
Relapse
Timepoint
Before and after engaging the second and fourth week , the second month, third month and sixth month
Method of measurement
Questionnaire bak, Examination physice

Secondary outcomes

1

Description
Inside effect
Timepoint
Control in the secondand fourth week, second, third and sixthmonths
Method of measurement
According to condition and observable clinical trait of patient

Intervention groups

1

Description
Intervention: Ocimum Basilicum essential oil applied locally to the forehead of the patient, every eight hours, with doses of 2,4,6 for 6 months.
Category
Treatment - Drugs

2

Description
Control group: To preparation the drug, using liquid paraffin solvent and the control group is given paraffin without ocimum basilicum 's oil .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr bahrami`s office.
Full name of responsible person
Parviz Bahrami
Street address
Crossroad bank
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 1064
Email
mahdie.ahmadifar@yahoo.com

2

Recruitment center
Name of recruitment center
Rahimi Hospital Clinic
Full name of responsible person
Mahdieh Ahmadifard
Street address
Field of 22 Bahman
City
Khorramabad
Province
Lorestan
Postal code
6817746361
Phone
+98 66 3320 0103
Email
mahdie.ahmadifar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalani
Street address
The end of Razi street, 60 metric
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3320 4007
Email
pr@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Science & technology park
Full name of responsible person
Mahdieh Ahmadifard
Position
Expert
Latest degree
Master
Other areas of specialty/work
Others
Street address
Firmaments 10, street 60m
City
KHorramabad
Province
Lorestan
Postal code
6815144312
Phone
+98 66 1320 0103
Fax
Email
mahdie.ahmadifar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Parviz Bahrami
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 1320 5111
Fax
Email
drbahrami2003@yahoo.ca
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Science and Technology Park
Full name of responsible person
Mahdieh Ahmadifard
Position
Expert
Latest degree
Master
Other areas of specialty/work
Industrial Engineering
Street address
Field of 22 Bahman
City
Khorramabad
Province
Lorestan
Postal code
6817746361
Phone
+98 66 3320 0103
Fax
Email
mahdie.ahmadifar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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