Effect of Ginger capsules on Pain Reduction in Patients with Migraine Headaches Purpose
Design
This clinical trial randomized with software; single blind in which 80 patient with Migraine headache with inclusion criteria divided into two groups of intervention and control
Settings and conduct
This study is performed on referrer to private offices and clinics in Shahrekord in single blind. 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 and neither the patient nor the doctor has any information about the type of medication. And only when analyzing the data will the names of each individual and his drug be identified to complete the information profile of the patients by mentioning the name of the drug received by them. In that tester, they do not know the type of drug received.The intervention group, in addition to routine treatments, receive ginger powder. The control group receives placebo in addition to routine treatments orally.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years; history of migraine headache before the study based on IHS criteria; headache from moderate to severe less than six days by visual analogue scale(Vas) score; having no disease such as renal failure, liver disease, heart disease, active stomach ulcer, and diabetes.
Intervention groups
The treatment group receives two ginger capsules of 250 along with 500 mg/day Depakene orally. The control group receives 500 mg/day Depakene alone daily that is their routine therapy .
Main outcome variables
The severity of headache; the number of headaches per month; sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220818055740N2
Registration date:2022-09-27, 1401/07/05
Registration timing:retrospective
Last update:2022-09-27, 1401/07/05
Update count:0
Registration date
2022-09-27, 1401/07/05
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
2019-06-29, 1398/04/08
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
2019-06-29, 1398/04/08
Actual recruitment end date
2019-09-01, 1398/06/10
Trial completion date
empty
Scientific title
Determination of the therapeutic efficacy of ginger in the treatment of migraine headaches
Public title
Determination of the therapeutic efficacy of ginger in the treatment of migraine headaches
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Age between 18 to 65 years; history of migraine headache before performing the study based on IHS criteria; headache from moderate to severe less than six days by visual analogue score(Vas); absence of diseases such as liver, heart, active stomach ulcer, diabetes and renal failure.
Exclusion criteria:
Exclusion criteria: Abnormal vital signs during the study;, new abnormal findings during CT scan; dissatisfaction patients to continue the study;, and observation of drug sensitivity.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Actual sample size reached:
80
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, and etc. The sequence of assignment of the participants will be determined by the software and each assignment will be put inside each envelope respectively. At the time of 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)
Single blinded
Blinding description
The single 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 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
Not 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
Kashani Blvd, Shahrekord University of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.SKUMS.REC.1398.018
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Migraine headache
Timepoint
One month after intervention
Method of measurement
VAS, PSQI, MIDAS questionnaires
Secondary outcomes
1
Description
Migraine headache
Timepoint
One month after intervention
Method of measurement
VAS, PSQI, MIDAS questionnaires
Intervention groups
1
Description
The control group received 500 mg/day Depakene orally daily once for sixteen weeks mgmanufactured by Zintoma (Gol darou Co.)
Category
Diagnosis
2
Description
Intervention group: The treatment group received two ginger capsules 250mg along with 500 mg/day Depakene manufactured by Zintoma (Gol darou Co.) orally for sixteen weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital of Shahrekord
Full name of responsible person
Nahid Jivad
Street address
Kashani Hospital, Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord
City
Shahrekod
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Fax
+98 38 3334 9506
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
Esfandiar Heydarian
Street address
Shahrekord University of Medical Sciences, Vice Chancellor of Research and Technology, Kashani Blvd, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
heydarian.e@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
Specialist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital, Shahrekord University of Medical Sciences, Parastar Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
818718791
Phone
+98 38 3335 1031
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 of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
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
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
818718791
Phone
+98 38 3335 1031
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