Melatonin and vitamin drip for pain relief in fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial examines the combined use of an intravenous immunonutrition vitamin drip and oral melatonin in adults with fibromyalgia. Participants will receive either the active combination or placebo once weekly for five weeks, with assessments of pain, quality of life, sleep, fatigue, and inflammatory markers. Primary outcomes include changes in pain and quality of life using validated scales, along with patient-perceived change and central sensitization measures. Secondary outcomes cover sleep quality, fatigue, and biomarkers. The study is conducted at the Immunonutrition Unit of the University of Thessaly in Greece, led by the university with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult patients diagnosed with Fibromyalgia Speak and understand the Greek language Consent to participate

Exclusion Criteria:

Children and adolescents Diagnosed with other chronic pain disorders or autoimmune disease Recent modification of their treatment (within 3 months) Pregnant and breastfeeding women Patients with severe renal or cardiac disease, cancer, infection, epilepsy

Where it's running

• Immunonutrition Unit, Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
  Larissa, Greece Recruiting

Study contacts

• Principal investigator: Maria G. Grammatikopoulou, Assistant Professor — Assistant Professor on Nutrition-Dietetics, at the Department of Medicine, University of Thessaly, Greece
• Study coordinator: Arriana Gkouvi, MD, MSc, PhDc
• Email: argkouvi@uth.gr
• Phone: 00302413502875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.