Evaluation of efficacy of Pimpinella anisum L. topical oil on migraine headache
Design
Two groups of interventional and control groups, which were given as drug and placebo, were randomized with double-blind clinical trial including 50 patients
Settings and conduct
Patients referring to the neurologist at Imam Reza and Shahid Faghihi clinics are referred to the researcher after the diagnosis and examination of the conditions for entry into the study. The researcher give the patient their medications, which is already coded by a pharmacist after the preparation, and medications and placebo cans are the same so that the researcher and the patient are not aware of the medication. After 6 weeks of drug consumption, the drug codes and patient records will be provided to the consultant for analysis.
Participants/Inclusion and exclusion criteria
Entry criteria:age between 18-65 ؛at least 2 episodes in 3 months
Criteria of failure to enter:pregnancy ؛ other neurological disorder ؛ cardiac diseases
Intervention groups
The two intervention and control groups that received the Anisone Cream Intervention Group (7%) and the placebo or non-anise extract cream were used for 6 weeks during the onset of a migraine attack, so that the patient should massage 2cc of the cream in bilateral temporal area on migraine attack
Main outcome variables
The frequency of headaches, the average duration of each headache, the average severity of each headache, the amount of consumption of analgesics
General information
Reason for update
Acronym
تاثیر انیسون بر میگرن
IRCT registration information
IRCT registration number:IRCT20140108016143N2
Registration date:2018-07-27, 1397/05/05
Registration timing:retrospective
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7589
Email address
mosavath@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
empty
Scientific title
Evaluation of efficacy of Pimpinella anisum L. topical oil on migraine headache
Public title
anisum effect on migrane headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-65
Migraine
Having at least two migraine attacks per month over the past three months
Exclusion criteria:
pregnancy,
lactation
any other neurological disorder
known allergy to anise and/or related products
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Actual sample size reached:
37
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization by 4numbered blocks included 2 intevention patient and 2 control patient
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo are coded and given to patients in the same container, so that neither clinical care nor patient information is available on how to distribute it
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
-
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SUMS.MED.REC.1396.55
Health conditions studied
1
Description of health condition studied
migrane headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Frequency of headache
Timepoint
week 0,3,6
Method of measurement
The patient records daily headaches
2
Description
quality of life
Timepoint
week 0 , 3 ,6
Method of measurement
headache impact test-6 (HIT-6) questionnaire
3
Description
total analgesic consumption
Timepoint
week 0,3,6
Method of measurement
The number of the medication in each interval is recorded on a daily basis by the patient
4
Description
headache duration
Timepoint
week 0 , 3 ,6
Method of measurement
The patient records daily headaches duration
5
Description
headache severity
Timepoint
week 0 , 3 ,6
Method of measurement
The patient records daily headaches severity from 0 to 10
Secondary outcomes
1
Description
Any observed adverse event
Timepoint
Sixth week after intervention
Method of measurement
self reporting of patients
Intervention groups
1
Description
Intervention group: The intervention group is given anise cream 7%, which is an anion blend of the extract and cold cream base and prepared as cream for 7%. During the onset of a headache, the patient consumes 2 cc of it in the temporal region. It is allowed to use other analgesics if it does not resolve up to half an hour later. During the course of a 6-month period, the patient's routine drugs such as neurotriptilin, Depakin, and etc will not be discontinued.
Category
Treatment - Drugs
2
Description
Control group: This group contains only cold cream base. During the onset of a headache, the patient experiences 2 cc of it in the temporal region. It is allowed to use other analgesics if it does not resolve up to half an hour later. During the course of a 6-month period, the patient's routine drugs such as neurotriptilin, Depakin, and ... will not be discontinued.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi clinic
Full name of responsible person
Amin Moayedfard
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
amin0moayed@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Amin Moayedfard
Street address
Namazi squre
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 3212 7009
Email
amin0moayed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71356-44144
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Amin Moayedfard
Position
student of medical science
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zand
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 1234 8550
Email
amin0moayed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr seyed hamdollah mosavat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
zand
City
shiraz
Province
Fars
Postal code
7135717344
Phone
+98 71 1234 8550
Email
mosavath@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin Moayedfard
Position
MD, Candidate of general practition
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
zand st
City
Shiraz
Province
Fars
Postal code
-7135717344
Phone
+98 71 3233 7589
Email
amin0moayed@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any analysis that leads to a new finding
From where data/document is obtainable
Research Center for Traditional Medicine and History of Medicine,
Shiraz University of Medical Sciences, Shiraz, Iran.
What processes are involved for a request to access data/document
Submit your written request to the Research Center for Traditional Medicine and History of Medicine in person and indicate the reason for using this data.