Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Conventional Therapy |
|
| Group 2 | Placebo Comparator | Nutraceutical Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol 80 mg | Drug | Propranolol 40-80 mg/day |
| |
| Magnesium 400Mg |
| Measure | Description | Time Frame |
|---|---|---|
| migraine intensity using The visual analog scale (VAS score) | 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. | 3 months |
| migraine duration | To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better. | 3 months |
| MIDAS score (Migraine Disability Assessment) Score | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the frequency of migraine attacks | Number of participants with the change in the frequency of migraine attacks. Less frequency, the better. | 3 months |
| side effect profile | 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. |
Not provided
Inclusion Criteria:
Adults aged 18-60 years
Exclusion Criteria:
• - Chronic migraine (>15 headache days/month)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Kamal Tolba, Associate professor | Contact | 01067789982 | mka05@fayoum.edu.eg |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29229375 | Background | Charles A. The pathophysiology of migraine: implications for clinical management. Lancet Neurol. 2018 Feb;17(2):174-182. doi: 10.1016/S1474-4422(17)30435-0. Epub 2017 Dec 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011433 | Propranolol |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Magnesium 400 mg daily |
|
| 3 months |
| patient satisfaction | 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. | 3 months |
| D009422 | Nervous System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |