Neuro-Complex & Multi Supplements for Migraine Prevention

ConditionsMigraine Headache Migraine Migraine in Adults

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBenfida, a department of Handi-Move

About this trial

The goal of this prospective, monocentric, open-label, non-randomized and single arm study is to evaluate a reduction of migraine days per months (MDM) by 25% by using the combined supplementation with Neuro-Complex \& Multi after 8 weeks of product intake on participants with diagnosis of migraine meeting the criteria of the International Classification of Headache Disorders (ICHD-3) (with or without aura).

The main endpoint of this clinical trial is :

The mean changes in migraine days per month (MDM) after 8 weeks of supplementation.

Participants will:

Orally consume two caps of each product (taken at the same time) daily, one in the morning and one at the lunchtime preferably during meal, for 8 weeks after a running period of 8 weeks without supplementation. Intake will be initiated from the day of follow-up visit (V1) after all study procedures being performed until the day of the end-of-study visit (V2).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female between 18 and 75 years;

Diagnosis of migraine meeting the criteria of the International Classification of Headache Disorders (ICHD-3) (with or without aura)

At least 5 attacks fulfilling the criteria below

Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

Disqualifiers

Other primary head pain disorders such as but not restricted to tension-type headache, cluster headache, fibromyalgia;

Secondary head pain due to trauma, injury, infections;

Medication overuse for headache defined as acute headache medication >10-15 days per month depending on the half-life of the medication (left to PI discretion);

Severe medical conditions affecting absorption and metabolism of the product, including but not restricted to chronic use of laxatives;

Trial design

Design model

Single group

Treatments tested in this trial

Neuro-Complex and Multi
Dietary supplement
Participants will orally consume 2 caps of each product (taken at the same time) daily, one in the morning and one at the lunchtime preferably during meal, for 8 weeks after a running period of 8 weeks without supplementation. Intake will be initiated from the day of follow-up visit (V1) after all study procedures being performed until the day of the end-of-study visit (V2). Participants will take 1 cap of each product simultaneously twice a day directly in their mouth.

Treatment groups

120 Participants

are divided into 1 treatment group

Group A: Supplementation Arm - Neuro-Complex and Multi CombinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Reduction of migraine days per month (MDM) by 25% by using the combined supplementation with Neuro-Complex & Multi after 8 weeks of product intake

Mean change of migraine days per month (MDM)

Time frame