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The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers

NCT06893822 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Chronic Pain
  • Central Sensitisation
  • Peripheral Sensitization
  • Neuroinflammatory Response

Interventions

DIETARY_SUPPLEMENT

Griffonia simplicifolia

Griffonia simplicifolia 1x/day

OTHER

Placebo

Placebo 1x/day

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2025-12-20
Completion
2025-12-20

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06893822 on ClinicalTrials.gov