Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT06893822

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

Led by Medical University of Graz · Updated on 2025-06-17

20

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 99 years
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Kidney or liver failure
  • Neurological, dermatological, or cardiovascular diseases
  • Chronic pain or use of painkillers
  • Use of antidepressants
  • Use of MAO inhibitors
  • Use of sleep medication
  • Use of St. John's wort
  • Allergy to Griffonia simplicifolia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Graz

Graz, Austria, 8010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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