Protocol summary
-
Study aim
-
Determination of the effect of Phytosomal curcumin supplementation on the severity, frequency, duration of headache and inflammatory factors and oxidative stress on patients with migraine
-
Design
-
Clinical trial, randomized, double-blind, randomized control group of 70 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. Phytosomal curcumin 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 migraine 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
-
Intervention groups
-
Intervention group: Phytosomal curcumin capsule, containing 250 mg curcumin once a day. Control group: 1 capsule containing 250 mg of maltodextrin.
-
Main outcome variables
-
Before and after the intervention; the severity; duration, and frequency of headache, Sleep quality, as well as serum nitric oxide (NO) and total antioxidant capacity (TAC), TOS, SOD, MDA, CRP will be evaluated.
General information
-
Reason for update
-
To enhance the statistical power of the study, we propose increasing the sample size to 70 participants and distinguishing between primary and secondary outcomes.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201129049534N2
Registration date:
2021-06-23, 1400/04/02
Registration timing:
prospective
Last update:
2025-06-03, 1404/03/13
Update count:
2
-
Registration date
-
2021-06-23, 1400/04/02
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-04-04, 1401/01/15
-
Expected recruitment end date
-
2022-07-06, 1401/04/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of phytosomal curcumin supplementation on severity, frequency, duration of headache and inflammatory factors and oxidative stress in patients with migraine
-
Public title
-
Effect of phytosomal curcumin supplementation on patients with migraine
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients who agree to participate in the study and complete the informed consent form.
Diagnosis of migraine headache by a neurologist using the third edition of the International Headache Disorders Questionnaire.
Age: 18 to 80 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
-
Age
-
From 18 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
70
-
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 phytosomal curcumin or placebo supplements.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
For researchers to be blind, phytosomal curcumin and placebo capsules are purchased equally from Sami labs Ltd., India in shape, colour 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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Migraine headache
-
ICD-10 code
-
G44.3
-
ICD-10 code description
-
Migraine headache
Primary outcomes
1
-
Description
-
Severity of migraine headache
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
VAS scale
2
-
Description
-
Frequency of migraine headache
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Number of migraine headache attacks per month
3
-
Description
-
Duration of migraine headache
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
The average duration of migraine headache attacks per hour per headache
4
-
Description
-
Quality of life
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Questionnaire
5
-
Description
-
Sleep quality
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Sleep quality questionnaire
Secondary outcomes
1
-
Description
-
Malondialdehyde (MDA)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Calorimetry
2
-
Description
-
Superoxide dismutase (SOD)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Calorimetry
3
-
Description
-
Total oxidant status (TOS)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Calorimetry
4
-
Description
-
Total Antioxidant Capacity (TAC)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Calorimetry
5
-
Description
-
C reactive protein (CRP)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Elisa
6
-
Description
-
Nitric Oxide (NO)
-
Timepoint
-
At baseline and end of the study
-
Method of measurement
-
Elisa
Intervention groups
1
-
Description
-
The intervention group will receive a capsule containing Phytosomal curcumin in the amount of 250 mg of curcumin once a day after breakfast for 8 weeks.
-
Category
-
Treatment - Drugs
2
-
Description
-
The control group will receive capsule (1 capsule) containing a placebo. Each capsule contains 250 mg of maltodextrin for 8 weeks.
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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.
-
Comments
-