Protocol summary
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Study aim
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The effect of alpha-lipoic acid supplementation on the clinical symptoms of migraine, serum lactate levels, vascular adhesion molecule, oxidative status, nitric oxide, in women with migraine
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Design
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Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
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Settings and conduct
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Participants will be selected from among women with migraines who go to the special clinic of Imam Musa Sadr Hospital in Isfahan. According to the case file of the sick people, the patients will be examined according to the criteria for entering the study and the people who have the conditions to participate in the study will enter the study. The study was two-way blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) Willingness to participation in the study;
2) Diagnosis of migraine by a neurologist based on ICHD-3 criteria.
3)Age 20 to 50 years.
Exclusion criteria:
1) History of any allergies, intolerances or harmful drug reactions to the supplement under study
2) History of intestinal bypass.
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Intervention groups
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Patients in the intervention group will receive 300 mg alpha-lipoic acid twice a day and control group will receive placebo.
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Main outcome variables
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The effects of Alpha-lipoic acid supplement on clinical signs of migraine (severity , frequency and duration), MHI, HIT-6, Nitric oxide, Lactate, VCAM-I, Oxidative status, in woman with migraine is assessed.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161203031212N3
Registration date:
2020-11-09, 1399/08/19
Registration timing:
registered_while_recruiting
Last update:
2021-04-05, 1400/01/16
Update count:
1
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Registration date
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2020-11-09, 1399/08/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-22, 1399/08/01
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Expected recruitment end date
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2020-11-21, 1399/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of alpha-lipoic acid supplementation on oxidative stress status, inflammatory markers, VCAM-I serum levels, lactate and clinical symptoms in women with migraine.
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Public title
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The effect of alpha-lipoic acid on migraine.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participation in the study.
Diagnosis of migraine by a neurologist based on ICHD-3 criteria.
Age 20 to 50 years.
Non-menopausal women.
Exclusion criteria:
History of any allergies, intolerances or adverse drug reactions to the supplement.
Pregnancy and lactation.
History of intestinal bypass.
Follow a special diet for the past 6 months.
Smoking or alcohol.
Take any supplements.
Cardiovascular disease, diabetes, liver, kidney, thyroid, malignant disease and other neurological disorders are diagnosed based on the patient interview.
Start taking the new drug within the last 1 month
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Randomization within each block will be done based on a table of random numbers using a valid random number generation website.Reputable website for generating random numbers:
https://www.sealedenvelope.com/simple-randomiser/v1/lists
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Supplementary and placebo packages will be prepared and coded by Raha Pharmaceutical Company and are completely the same in terms of all appearance, color, smell and label, and each patient is randomly assigned a number using the order obtained from the reputable website. And the researcher and patients will not be informed of the contents of the packages until the end of the study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-11, 1399/07/20
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.436
Health conditions studied
1
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Description of health condition studied
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migraine
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ICD-10 code
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G43.0
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ICD-10 code description
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Migraine without aura
Primary outcomes
1
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Description
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Migraine severity
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Visual analogue scale
2
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Description
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Migraine frequency .
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Clinical examination.
3
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Description
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Migraine duration
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Clinical examination.
4
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Description
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Headache impact test
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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HIT questionnaire
5
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Description
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C-reactive protein (CRP)
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
6
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Description
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Serum glutathion
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
7
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
8
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Description
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Total oxidant capacity
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
9
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Description
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Malondialdehyde
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
Secondary outcomes
1
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Description
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vascular cell adhesion molecule-1
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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It will be measured by ELISA kit.
2
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Description
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Serum lactate
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
3
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Description
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Serum Nitric Oxide
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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Colorimetric method.
4
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Description
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Depression
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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DASS questionnaire
5
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Description
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Anxiety
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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DASS questionnaire
6
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Description
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Stress
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Timepoint
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At baseline and after 3 month.
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Method of measurement
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DASS questionnaire.
Intervention groups
1
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Description
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People will receive 300 mg of alpha-lipoic acid supplement twice a day for 3 months. The supplement and placebo will be provided by Raha Pharmaceutical Company.
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Category
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Treatment - Other
2
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Description
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The control group will receive an alpha-lipoic acid placebo twice daily for 3 months. Supplements and placebo will be provided by Raha Pharmaceutical Company.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available