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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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This planned study is based on a randomized, placebo-controlled cross-over design. Griffonia 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 2002/46/EC. Several clinical studies have examined the efficacy of 5-HTP in chronic pain conditions. The 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. For 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. Furthermore, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 20
Treatments
Experimental: Verum (Griffonia simplicifolia) - Placebo
Participants receive Griffonia s. 1x day for 28 days, 4 weeks wash out will follow, then they receive placebo for 28 days.
Placebo_comparator: Placebo - Verum (Griffonia simplicifolia)
Participants receive placebo 1xd ay for 28 days, 4 weeks washout will follow, then they receive Griffonia s. for 28 days
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov