Comparative Study of Nutraceuticals vs. Conventional Prophylactic Therapy in the Management of Migraine

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFayoum University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• - Chronic migraine (>15 headache days/month)

- Use of other prophylactic treatments in past month

- History of secondary headaches

- Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propranolol 80 mg

    Drug

    Propranolol 40-80 mg/day

  • Magnesium 400Mg

    Drug

    Magnesium 400 mg daily

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

migraine duration

To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better.

Time frame
3 months
3

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.

Time frame
3 months

Secondary outcomes

1

changes in the frequency of migraine attacks

Number of participants with the change in the frequency of migraine attacks. Less frequency, the better.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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