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Not yet recruiting NCT07147972

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

Phase III Interventional Migraine Nutraceuticals

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propranolol 80 mg, Magnesium 400Mg.
Who it may be relevant to
Registry conditions: Migraine, Nutraceuticals. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Propranolol 80 mg
    Propranolol 40-80 mg/day
  • Drug Magnesium 400Mg
    Magnesium 400 mg daily

Primary outcome measures

  • migraine intensity using The visual analog scale (VAS score) [Time frame: 3 months]
  • migraine duration [Time frame: 3 months]
  • MIDAS score (Migraine Disability Assessment) Score [Time frame: 3 months]
Secondary outcome measures (3)
  • changes in the frequency of migraine attacks [Time frame: 3 months]
  • side effect profile [Time frame: 3 months]
  • patient satisfaction [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07147972 · Management of Migraine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗