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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in spontaneous pain intensity
研究概览
简要总结
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.
详细描述
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.
An effect on peripheral sensitization speaks in favor of use in acute somatic pain. However, if the effect can be explained by central mechanisms, its use would be recommended in chronic or neuropathic pain. 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.
The following questions were be answered in this study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Verum (Griffonia simplicifolia) - Placebo
Participants receive Griffonia s. 1x day for 28 days, 4 weeks wash out will follow, then they receive placebo for 28 days.
干预措施: Griffonia simplicifolia (Dietary Supplement)
Verum (Griffonia simplicifolia) - Placebo
Participants receive Griffonia s. 1x day for 28 days, 4 weeks wash out will follow, then they receive placebo for 28 days.
干预措施: Placebo (Other)
Placebo - Verum (Griffonia simplicifolia)
Participants receive placebo 1xd ay for 28 days, 4 weeks washout will follow, then they receive Griffonia s. for 28 days
干预措施: Placebo (Other)
Placebo - Verum (Griffonia simplicifolia)
Participants receive placebo 1xd ay for 28 days, 4 weeks washout will follow, then they receive Griffonia s. for 28 days
干预措施: Griffonia simplicifolia (Dietary Supplement)
结局指标
主要结局
Change in spontaneous pain intensity
时间窗: -->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
is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)
次要结局
- 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)
- Psychological Questionnaires(All four study visits: BDI-II, BAI, PSQI, WHO-5 questionnaire, Modul "Memory" of the Neuropsychological Assessment Battery (NAB); Only at the 2nd and 4th study visit: Medication Adherence Report Scale (MARS-d).)