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NCT Number: NCT07147972

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Nutraceuticals

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol 80 mg

Drug

Propranolol 40-80 mg/day

Magnesium 400Mg

Drug

Magnesium 400 mg daily

Primary outcomes

  1. migraine intensity using The visual analog scale (VAS score)

    Time frame: 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.

  2. migraine duration

    Time frame: 3 months

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

  3. MIDAS score (Migraine Disability Assessment) Score

    Time frame: 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 outcomes

  1. changes in the frequency of migraine attacks

    Time frame: 3 months

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

  2. side effect profile

    Time frame: 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.

  3. patient satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Kamal Tolba, Associate professor

CONTACT

[email protected]

01067789982

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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