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

ConditionsChronic PainCentral SensitisationPeripheral SensitizationNeuroinflammatory Response
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMedical University of Graz

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

pregnancy or breastfeeding.

renal or hepatic insufficiency

neurological/dermatological/cardiovascular diseases

chronic pain and/or use of analgesics

Trial design

Design model

Crossover

Treatments tested in this trial

  • Griffonia simplicifolia

    Dietary supplement

    Griffonia simplicifolia 1x/day

  • Placebo

    Other intervention

    Placebo 1x/day

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Verum (Griffonia simplicifolia) - PlaceboExperimental treatment 2 interventions
Group B: Placebo - Verum (Griffonia simplicifolia)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in spontaneous pain intensity

is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)

Time frame
-->Day 0 -->Day 28 before repeated heat application --> Day 28 1 hour after repeated heat application --> Day 56 -->Day 84 before repeated heat application -->Day 84 1 hour after repeated heat application

Secondary outcomes

1

Change in Allodynia

measured in radial distance in mm

Time frame
-->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 84 before repeated heat application -->Day 84 1 hour after repeated heat application
2

Change in Hyperalgesia

measured with pinpricks, that are preset different peak stimulus. A numerical scale (0-100) is used to measure how painful the stimulus is.

Time frame
-->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 84 before repeated heat application -->Day 84 1 hour after repeated heat application
3

Change in heat detection threshold

measured in degrees C°

Time frame
->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 84 before repeated heat application -->Day 84 1 hour after repeated heat application
4

Change in heat pain threshold

measured in degrees C°

Time frame
-->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 --> Day 84 before repeated heat application -->Day 84 1 hour after repeated heat application

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov
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