The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers
RecruitingNot applicableNCT06893822
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Chronic Pain
- Central Sensitisation
- Peripheral Sensitization
- Neuroinflammatory Response
- Interventions
- Dietary supplement: Griffonia simplicifolia
- Other: Placebo
- Sponsor
- Medical University of Graz
- Start date
- 2025-09-12
- Primary completion
- 2025-12-20
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Austria
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06893822