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

NCT07147972 | Not Yet Recruiting Phase 3

• 1 other identifier: Management of Migraine
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine; Nutraceuticals

Keywords

Migraine; Nutraceuticals

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• changes in the frequency of migraine attacks

  3 months

• side effect profile

  3 months

• patient satisfaction

  3 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Conventional Therapy

Drug: Propranolol 80 mg

Group 2

PLACEBO COMPARATOR

Nutraceutical Therapy

Drug: Magnesium 400Mg

Interventions

Propranolol 80 mg DRUG

Propranolol 40-80 mg/day

Group 1

Magnesium 400Mg DRUG

Magnesium 400 mg daily

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• - 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

Sponsors & Collaborators

• Fayoum University: lead

Related Publications (1)

• 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.

  PMID: 29229375 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Propranolol; Magnesium

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Marwa Kamal Tolba, Associate professor

CONTACT

01067789982; mka05@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor clinical pharmacy department -faculty of pharmacy- fayoum university

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 29, 2025
• Study Start: August 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share