Anti-migraine effects of roasted barley tea (Hordeum vulgare L.) in patients affected to migraine headaches admitted to the Clinics of headache related to Shahrekord University of Medical Sciences
Design
This study is a clinical trial and phase 3, 40 patients in the headache clinics aged 50 to 18 years with headaches are divided into two groups by simple random allocation. In double-blinding, the patient chooses one of the two drugs randomly and the name of each person and the code of the drug provided to him by the secretary is registered. The control group received a routine treatment with a placebo. The intervention group, in addition to standard treatment, receives barely tea twice daily and each time gets 3 grams with 500 cc of boiling water for 7 minutes for 6 weeks.
Settings and conduct
Patients in this study are affected by migraine headaches admitted to the Clinics of headache related to the Shahrekord University of Medical Sciences. 40 patients in the headache clinics aged 50 to 18 years with headaches who have migraines according to the International Headache Association (IHS) are divided into two groups by simple random allocation.
The double blindness of the study was performed in this process. Neither the patient nor the doctor was not aware of the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria were including the person's consent to participate in the study, not having dependent on alcohol or narcotic drugs and not having a history of cognitive impairment
Exclusion criteria: Suffering from diabetes or any other underlying disease, having a history of allergy to aromatic substances
Intervention groups
Intervention group: Patients who receive routine treatment with barley tea.
Control group: Patients who receive routine treatment.
Main outcome variables
Migraine headaches.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220818055740N4
Registration date:2023-05-29, 1402/03/08
Registration timing:retrospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Nahid Jivad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 1031
Email address
jivad@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
2017-09-01, 1396/06/10
Actual recruitment end date
2017-12-31, 1396/10/10
Trial completion date
2023-03-01, 1401/12/10
Scientific title
The analgesic effect of barley tea (Hordeum vulgare L.) on patients with migraine headaches
Public title
The analgesic effect of barley tea (Hordeum vulgare L.) on patients with migraine headaches
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria were including the person's consent to participate in the study, not having dependent on alcohol or narcotic drugs and not having a history of cognitive impairment, not taking long-term sedatives and other psychiatric drugs
Exclusion criteria:
Suffering from diabetes or any other underlying disease, having a history of allergy to aromatic substances, and having a proven problem with the sense of smell.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the participants to the intervention and control groups will be done using random allocation software. Then, many envelopes will be prepared according to the number of participants in the study. Then, number 1 will be recorded on the first envelope, number 2 on the second envelope, etc. The sequence of assignments of the participants will be determined by the software and each assignment will be put inside each envelope respectively. At the time of the study, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention and control groups according to the option recorded inside the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The double blindness of the study was performed in this process that at first, the mentioned drugs received code without any labels and the patient selected one of the two drugs randomly. Then, the name of each person and the drug code provided to him were registered by the secretary. Neither the patient nor the doctor was not aware of the type of medication. The name of each person and his drug was specified only during analyzing the data and completed the patients' information profile by mentioning the name of the drug received by them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord Town,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.SKUMS.REC.1396.66
2
Ethics committee
Name of ethics committee
Street address
City
Postal code
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.SKUMS.REC.1396.66
Health conditions studied
1
Description of health condition studied
Migraine Headaches
ICD-10 code
F60
ICD-10 code description
Specific personality disorders
Primary outcomes
1
Description
The rate of pain intensity for headache after intervention
Timepoint
6 weeks performed intervention. then, The rate of pain intensify was measured.
Method of measurement
Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who receive routine treatment with barley tea
Category
Diagnosis
2
Description
Control group: Patients who receive routine treatment
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Nahid Jivad
Street address
Shahrekord University of Medical Sciences, Kashani Hospital, Parastar Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jivad@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Elham Raisi
Street address
Shahrekord University of Medical science, Deputy for Research and Technology, Kashani Blvd,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
Jivad@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital, Parastar Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
Jivad@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital, Parastar Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
Jivad@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Parastar Street, Kashani Hospital, Shahrekord University of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jivad@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD