Neuro-Complex & Multi Supplements for Migraine Prevention
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
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
Treatments tested in this trial
- Neuro-Complex and Multi
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Benfida, a department of Handi-Move
Lead sponsor
Artialis
Collaborator
Source ClinicalTrials.gov