[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584781":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum (Griffonia simplicifolia) - Placebo","EXPERIMENTAL","Participants receive Griffonia s. 1x day for 28 days, 4 weeks wash out will follow, then they receive placebo for 28 days.",[13,14],"Dietary Supplement: Griffonia simplicifolia","Other: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo - Verum (Griffonia simplicifolia)","PLACEBO_COMPARATOR","Participants receive placebo 1xd ay for 28 days, 4 weeks washout will follow, then they receive Griffonia s. for 28 days",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Griffonia simplicifolia","Griffonia simplicifolia 1x\u002Fday",[16,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo 1x\u002Fday",[16,9],[32],{"facility":5,"status":33,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Graz","8010","Austria","AT",{"type":39,"coordinates":40},"Point",[41,42],15.44197,47.06733,{"lat":42,"lon":41},[45,50],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Helmar Bornemann-Cimenti, PD Dr.med.univ Dr.scient.med.","CONTACT","4331638581103","helmar@bornemann@medunigraz.at",{"name":51,"role":52,"phone":26,"phoneExt":26,"email":26},"Helmar Bornemann-Cimenti, PD Dr.med.univ. Dr.scient.med.","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100584781","the-effect-of-griffonia-simplicifolia-on-pain-intensity-central-and-peripheral-sensitization-painmodulation-in-healthy-volunteers-100584781",false,"NCT06893822","The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers","The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers - A Randomized, Double-blinded, Placebo-controlled, Cross-over Study","Exclusion Criteria:\n\n* pregnancy or breastfeeding.\n* renal or hepatic insufficiency\n* neurological\u002Fdermatological\u002Fcardiovascular diseases\n* chronic pain and\u002For use of analgesics\n* intake of antidepressants\n* intake of MAO inhibitors\n* intake of sleep medication\n* intake of St. John's wort\n* allergy to Griffonia simplicifolia",true,"ALL","18 Years","99 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"NA","This planned study is based on a randomized, placebo-controlled cross-over design.\n\nGriffonia simplicifolia contains the serotonin-precursor 5-hydroxytryptophan (5-HTP), an endogenous amino acid. 5-HTP can cross the blood-brain barrier and is converted to serotonin. Low serotonin levels are associated with depression, anxiety disorders and sleep disorders, among others. Griffonia simplicifolia is marketed as a food supplement in accordance with EU Directive 2002\u002F46\u002FEC. Several clinical studies have examined the efficacy of 5-HTP in chronic pain conditions.\n\nThe data suggest a clinical analgesic efficacy, without, however, allowing conclusions about the underlying mechanisms. These have not yet been investigated in a human experimental pain model. The aim of the study is to investigate the influence of 5-HTP in peripheral and central sensitization, as well as descending inhibitory pathways by Quantitative Sensory Testing (QST). These findings are of great relevance for a better understanding of clinical efficacy.\n\nFor this purpose, \"repetitive phasic heat application\" is a validated method for achieving short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited for investigating the analgesic and anti-hyperalgesic effects of drugs.\n\nFurthermore, the influence of Griffonia simplicifolia on mood (depression, anxiety), memory, sleep quality and psychological well-being will be investigated by using psychological questionnaires as secondary target variables.",[74,75,76,77],"Chronic Pain","Central Sensitisation","Peripheral Sensitization","Neuroinflammatory Response",[23,79,80,75],"5-HTP","Peripheral Sensitisation","2025-06-12",{"date":83,"type":84},"2025-06-17","ACTUAL",{"date":86,"type":68},"2025-09-12",{"date":88,"type":68},"2025-12-20",{"name":5,"class":6},1]