NCT06893822 The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers
| NCT ID | NCT06893822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-09-12 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06893822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06893822 currently recruiting?
Yes, NCT06893822 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University of Graz to inquire about joining.
Where is the NCT06893822 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT06893822 clinical trial?
NCT06893822 is sponsored by Medical University of Graz. The trial plans to enroll 20 participants.
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