[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659343":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":44,"studyPopulation":15,"armGroups":45,"interventions":58,"overallOfficials":66,"centralContacts":71,"locations":80,"responsibleParty":100,"collaborators":15,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":15,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":15,"enrollmentInfo":112,"targetDuration":15,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":83,"whyStopped":15,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Thessaly","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":15},[9,13,16,18,20,22],{"measure":10,"description":11,"timeFrame":12},"VAS pain","Pain on a scale from 0 to 10 where 0 indicates \"no pain\" and 10 indicates \"the worst possible pain\"","5 weeks",{"measure":14,"description":15,"timeFrame":12},"Brief Pain Inventory (BPI)",null,{"measure":17,"description":15,"timeFrame":12},"Revised Fibromyalgia Impact Questionnaire (FIQR)",{"measure":19,"description":15,"timeFrame":12},"Functional Assessment of Chronic Illness Therapy (FACIT)",{"measure":21,"description":15,"timeFrame":12},"Patient Global Impression of Change (PGIC)",{"measure":23,"description":15,"timeFrame":12},"Central Sensitization Inventory (CSI)",[25,27,29,32,34],{"measure":26,"description":15,"timeFrame":12},"Epworth Sleepiness Scale (ESS)",{"measure":28,"description":15,"timeFrame":12},"Fatigue Severity Scale (FSS)",{"measure":30,"description":31,"timeFrame":12},"Inflammatory markers","CRP, ESR",{"measure":33,"description":15,"timeFrame":12},"Beck Depression Inventory (BDI)",{"measure":35,"description":15,"timeFrame":12},"Beck anxiety inventory (BAI)",{"allocation":37,"interventionModel":38,"interventionModelDescription":15,"primaryPurpose":39,"observationalModel":15,"timePerspective":15,"maskingInfo":40},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":41,"maskingDescription":15,"whoMasked":42},"SINGLE",[43],"PARTICIPANT","Recent data have shown the potential role of melatonin as an adjuvant treatment in fibromyalgia (FMS), as it appears to improve sleep quality, reduce pain, and improve patient- and physician-reported assessments of quality of life. In addition to melatonin, intravenous micronutrient therapy has also been reported to improve symptoms in patients with fibromyalgia. More specifically, the intravenous administration of a mixture of vitamins and trace elements has been associated with reductions in pain, fatigue, and the number of tender points, as well as improvements in mood, quality of life, and energy levels for daily activities in patients with FM. Following a review of the available literature, a randomized, placebo-controlled clinical trial will be conducted to evaluate the efficacy of the combined administration of melatonin and intravenous vitamin drip in patients with FMS compared with a control group receiving placebo.\n\nThe primary outcomes will include changes in pain and quality of life, assessed using the following validated instruments: the Visual Analogue Scale (VAS), the Revised Fibromyalgia Impact Questionnaire (FIQR), the Functional Assessment of Chronic Illness Therapy (FACIT), and the Brief Pain Inventory (BPI). Additional primary outcome measures will include the patient's subjective perception of change, assessed using the Patient Global Impression of Change (PGIC), and the degree of central sensitization, assessed using the Central Sensitization Inventory (CSI).\n\nThe secondary outcomes will include changes in sleep-related symptoms, assessed using the Epworth Sleepiness Scale (ESS); changes in fatigue, assessed using the Fatigue Severity Scale (FSS); changes in psychological symptoms, assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); and changes in inflammatory markers, specifically C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Immunonutrition","EXPERIMENTAL","Per os Melatonin 1mg every night half an hour before sleep and intravenous B-complex vitamin drip every week",[51],"Dietary Supplement: Melatonin 1mg and intravenous B-complex vitamin drip",{"label":53,"type":54,"description":55,"interventionNames":56},"Placebo","PLACEBO_COMPARATOR","Per os corn startch placebo capsules every night half an hour before sleep and intravenous N\u002FS 500mL drip every week",[57],"Dietary Supplement: Placebo",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":15},"DIETARY_SUPPLEMENT","Melatonin 1mg and intravenous B-complex vitamin drip","Patients will receive Melatonin 1mg half an hour before sleep every day and intravenous B-complex vitamin drip every week for a total of five weeks",[47],{"type":60,"name":53,"description":55,"armGroupLabels":65,"otherNames":15},[53],[67],{"name":68,"affiliation":69,"role":70},"Maria G. Grammatikopoulou, Assistant Professor","Assistant Professor on Nutrition-Dietetics, at the Department of Medicine, University of Thessaly, Greece","PRINCIPAL_INVESTIGATOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":15,"email":76},"Arriana Gkouvi, MD, MSc, PhDc","CONTACT","00302413502875","argkouvi@uth.gr",{"name":68,"role":74,"phone":78,"phoneExt":15,"email":79},"2413502813","mgrammat@uth.gr",[81],{"facility":82,"status":83,"city":84,"state":15,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Immunonutrition Unit, Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece","RECRUITING","Larissa","41100","Greece","GR",{"type":89,"coordinates":90},"Point",[91,92],22.42112,39.62847,{"lat":92,"lon":91},[95,97],{"name":96,"role":74,"phone":75,"phoneExt":15,"email":76},"Arriana Gkouvi, MD, PhDc",{"name":98,"role":74,"phone":99,"phoneExt":15,"email":79},"Maria G. Grammatikopoulou, As Professor","00302413502813",{"type":70,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"Arriana Gkouvi","MD, MSc, PhDc","100659343","melatonin-and-immunonutrition-for-pain-relief-in-fibromyalgia-100659343",false,"NCT07863232","Melatonin and Immunonutrition for Pain Relief in Fibromyalgia","Melatonin and Immunonutrition for Pain Relief in Fibromyalgia: a Randomized Controlled Trial","Inclusion Criteria:\n\nAdult patients diagnosed with Fibromyalgia Speak and understand the Greek language Consent to participate\n\nExclusion Criteria:\n\nChildren 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","ALL","18 Years",{"count":113,"type":114},60,"ESTIMATED","INTERVENTIONAL",[117],"NA","Fibromyalgia (FMS) is characterized by chronic musculoskeletal pain, sleep disturbances, and fatigue. It is not entirely clear how Bcomplex vitamins affect the human pain system, while at the same time there have been approaches that use melatonin in patients with FMS and report improvements in pain and sleep quality.\n\nThe purpose of this study is to investigate the efficacy of a combined immunonutrition and melatonin intervention in patients with FMS through a randomized clinical trial (RCT). The combined effect of immunonutrition and melatonin, administered intravenously once a week and orally respectively, versus placebo, will be examined in patients with FMS, for a period of 5 weeks. The primary endpoints concern the quantification of pain and quality of life, while the secondary endpoints are sleep quality, fatigue and inflammatory markers.",[120],"Fibromyalgia",[122,123,124,125,126,127,128],"immunonutrition","FMS","melatonin","vitamins","pain","sleep","quality of life","2026-10-01",{"date":131,"type":132},"2026-10-07","ACTUAL",{"date":134,"type":114},"2026-10",{"date":136,"type":114},"2027-10",{"name":5,"class":6},1]