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

NCT ID: NCT07147972

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Migraine Nutraceuticals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Conventional Therapy

Group Type ACTIVE_COMPARATOR

Propranolol 80 mg

Intervention Type DRUG

Propranolol 40-80 mg/day

Group 2

Nutraceutical Therapy

Group Type PLACEBO_COMPARATOR

Magnesium 400Mg

Intervention Type DRUG

Magnesium 400 mg daily

Interventions

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Propranolol 80 mg

Propranolol 40-80 mg/day

Intervention Type DRUG

Magnesium 400Mg

Magnesium 400 mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Ahmed Kamal Tolba

Associate professor clinical pharmacy department -faculty of pharmacy- fayoum university

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marwa Kamal Tolba, Associate professor

Role: CONTACT

01067789982

References

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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.

Reference Type BACKGROUND
PMID: 29229375 (View on PubMed)

Other Identifiers

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Management of Migraine

Identifier Type: -

Identifier Source: org_study_id

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