Determination of the effect of curcumin-piperine supplementation on the severity, frequency, duration of headache and inflammatory factors and oxidative stress after trauma
Design
Clinical trial, randomized, double-blind, randomized control group of 60 patients. Randomization is done using a valid website and 4-block method.
Settings and conduct
This clinical trial will be performed in the clinics of Khorshid Hospital and Al-Zahra Hospital. Curcumin piperine and placebo are administered in exactly the same packages to the patient. Patients and researchers will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: completing the consent form; diagnosis of post-traumatic headache by a neurologist.
Criteria for non-entry: consumption of anticoagulants such as warfarin, heparin, aspirin, and ...; pregnancy and lactation; follow a special diet in the last 3 months; use of herbal supplements in the last 3 months; history of pre-traumatic migraine headaches.
Intervention groups
Intervention group: three curcumin-piperine capsules, containing 500 mg curcumin and 5 mg piperine twice daily. Control group: 2 capsules containing 500 mg of maltodextrin.
Main outcome variables
Before and after the intervention; the severity; duration, and frequency of headache, as well as serum nitric oxide (NO) and total antioxidant capacity (TAC) and total oxidative capacity (TOS), CRP will be evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049534N2
Registration date:2021-06-23, 1400/04/02
Registration timing:registered_while_recruiting
Last update:2021-06-23, 1400/04/02
Update count:2
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
Mohammad bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
bagherniya@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin-piperine supplementation on post-traumatic headache symptoms, inflammatory and stress oxidative markers
Public title
Effect of curcumin-piperine supplementation on post-traumatic headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who agree to participate in the study and complete the informed consent form.
Diagnosis of post-traumatic headache by a neurologist using the third edition of the International Headache Disorders Questionnaire.
Age: 30 to 85 years old
Exclusion criteria:
Taking anticoagulants such as warfarin, heparin, aspirin, etc.
Pregnancy and lactation
Follow a special diet in the last 3 months
Use of herbal supplements in the last 3 months
History of pre-traumatic migraine headaches
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples generate random numbers using a reputable website: https://www.sealedenvelope.com/simple-randomiser/v1/lists. They are randomly assigned to one of two curcumin-piperine or placebo supplements.
Blinding (investigator's opinion)
Double blinded
Blinding description
For researchers to be blind, curcumin piperine and placebo capsules are purchased equally from Sami labs Ltd., India in shape, color and size. These capsules are coded by someone other than the researchers (A and B) and the researcher distributes them without knowing the type of capsules. Patients and researchers will not be aware of the capsule type until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar-jerib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.110
Health conditions studied
1
Description of health condition studied
Post-traumatic headache
ICD-10 code
G44.3
ICD-10 code description
Chronic post-traumatic headache
Primary outcomes
1
Description
Severity of post-traumatic headache
Timepoint
At baseline and end of the study
Method of measurement
VAS scale
2
Description
Frequency of post-traumatic headache
Timepoint
At baseline and end of the study
Method of measurement
Number of post-traumatic headache attacks per month
3
Description
Duration of post-traumatic headache
Timepoint
At baseline and end of the study
Method of measurement
The average duration of post-traumatic headache attacks per hour per headache
4
Description
Nitric oxide
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
5
Description
Total antioxidant capacity
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
6
Description
Total oxidative capacity
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
7
Description
C-Reactive Protein – CRP
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
At baseline and end of the study
Method of measurement
Mercury barometer
2
Description
Diastolic blood pressure
Timepoint
At baseline and end of the study
Method of measurement
Mercury barometer
3
Description
Quality of Life
Timepoint
At baseline and end of the study
Method of measurement
Quality of life questionnaire
Intervention groups
1
Description
Intervention group will receive a capsule containing curcumin-piperine in the amount of 500 mg of curcumin and 5 mg of piperine twice a day after breakfast and in the evening (a total of 1000 mg of curcumin and 10 mg of piperine daily) for 8 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive capsules (2 capsules) containing placebo. Each capsule contains 500 mg of maltodextrin (a total of 1000 mg of maltodextrin daily) for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Mehrnaz shojaei
Street address
Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehrnaz Shojaei
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@nutr.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study information will be published after the individuals are unidentified and after the project is completed.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further analysis
From where data/document is obtainable
Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
What processes are involved for a request to access data/document
After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.