RecruitingNot ApplicableNCT06893822

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


Sponsor

Medical University of Graz

Enrollment

20 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Exclusion Criteria9

  • pregnancy or breastfeeding.
  • renal or hepatic insufficiency
  • neurological/dermatological/cardiovascular diseases
  • chronic pain and/or use of analgesics
  • intake of antidepressants
  • intake of MAO inhibitors
  • intake of sleep medication
  • intake of St. John's wort
  • allergy to Griffonia simplicifolia

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Interventions

DIETARY_SUPPLEMENTGriffonia simplicifolia

Griffonia simplicifolia 1x/day

OTHERPlacebo

Placebo 1x/day


Locations(1)

Medical University of Graz

Graz, Austria

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NCT06893822


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