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

NCT06893822 | Recruiting

• 1 other identifier: 1308/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Central Sensitisation; Peripheral Sensitization; Neuroinflammatory Response

Keywords

Griffonia simplicifolia; 5-HTP; Peripheral Sensitisation; Central Sensitisation

Outcome Measures

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)

  -->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 (6)

• Change in Allodynia

  -->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

• Change in Hyperalgesia

  -->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

• Change in heat detection threshold

  ->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

• Change in heat pain threshold

  -->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

• Change in conditioned pain modulation

  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

Study Arms (2)

Verum (Griffonia simplicifolia) - Placebo

EXPERIMENTAL

Participants receive Griffonia s. 1x day for 28 days, 4 weeks wash out will follow, then they receive placebo for 28 days.

Dietary Supplement: Griffonia simplicifolia; Other: Placebo

Placebo - Verum (Griffonia simplicifolia)

PLACEBO COMPARATOR

Participants receive placebo 1xd ay for 28 days, 4 weeks washout will follow, then they receive Griffonia s. for 28 days

Dietary Supplement: Griffonia simplicifolia; Other: Placebo

Interventions

Griffonia simplicifolia DIETARY_SUPPLEMENT

Griffonia simplicifolia 1x/day

Placebo - Verum (Griffonia simplicifolia); Verum (Griffonia simplicifolia) - Placebo

Placebo OTHER

Placebo 1x/day

Placebo - Verum (Griffonia simplicifolia); Verum (Griffonia simplicifolia) - Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Griffonia simplicifolia lectins

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over design.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: September 12, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)