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

Not Applicable

Not yet recruiting

• Conditions: Migraine; Nutraceuticals
• Interventions: Drug: Propranolol 80 mg; Drug: Magnesium 400Mg

• Registration Number: NCT07147972
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-16
• Study Start: 2025-08-20
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Propranolol 80 mg	Conventional Therapy
Group 2	Magnesium 400Mg	Nutraceutical Therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.