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

Fayoum University

Status and phase: Not yet enrolling; Phase 3

Conditions: Nutraceuticals; Migraine

Treatments: Drug: Propranolol 80 mg; Drug: Magnesium 400Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07147972

Management of Migraine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Conventional Therapy

Treatment:

Drug: Propranolol 80 mg

Group 2

Placebo Comparator group

Description:

Nutraceutical Therapy

Treatment:

Drug: Magnesium 400Mg