Migraine, Nutraceuticals
Conditions
Keywords
Migraine, Nutraceuticals
Brief summary
Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Recent evidence suggests that nutraceuticals like magnesium, riboflavin, and coenzyme Q10 may provide a safer alternative. This study aims to compare the efficacy and tolerability of these two approaches.
Detailed description
Primary Objective: \- To compare the reduction in the frequency of migraine attacks between patients receiving conventional prophylactic therapy and those receiving a nutraceutical combination. Secondary Objectives: * To evaluate changes in migraine intensity (VAS score), duration, and MIDAS score. * To assess the side effect profile and patient satisfaction with both interventions.
Interventions
Propranolol 40-80 mg/day
DRUGMagnesium 400Mg
Magnesium 400 mg daily
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-60 years * \- Diagnosed with episodic migraine (ICHD-3 criteria) * \- ≥4 migraine attacks/month for the past 3 months * \- Willing to provide informed consent
Exclusion criteria
* • - Chronic migraine (\>15 headache days/month) * \- Use of other prophylactic treatments in past month * \- History of secondary headaches * \- Pregnancy or breastfeeding * \- Significant renal, hepatic, or cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| migraine intensity using The visual analog scale (VAS score) | 3 months | To evaluate changes in migraine intensity using the visual analog scale (VAS score) in both groups which is one of the pain rating scales. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one. |
| migraine duration | 3 months | To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better. |
| MIDAS score (Migraine Disability Assessment) Score | 3 months | To evaluate changes in MIDAS score (Migraine Disability Assessment) in both groups. Which is a validated, 5-item questionnaire designed to quantify the severity of headache-related disability over the past three months by assessing missed days and reduced productivity in work/school, household chores, and social/family activities. The total score, which can range from 0 to 270, indicates the overall impact of migraines on daily functioning, with higher scores signifying greater disability. MIDAS score. Disability. MIDAS grade ; 0-5. Little or no disability. I ; 6-10. Mild disability. II ; 11-20. Moderate disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the frequency of migraine attacks | 3 months | Number of participants with the change in the frequency of migraine attacks. Less frequency, the better. |
| side effect profile | 3 months | To calculate the % of patients who didn't experience side effects of treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction. |
| patient satisfaction | 3 months | To calculate the % of patients who were satisfied with the treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction. |
Contacts
Primary ContactMarwa Kamal Tolba, Associate professor
Outcome results
None listed