Psychophysiological Efficacy of Thorax Wraps With Ginger or Mustard Flour in Comparison to Wraps With Warm Water in Healthy Subjects - a Randomized, Placebo-controlled, Three-armed Study With Cross-over Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- changes in temperature
研究概览
简要总结
In integrative medicine wraps are applied for different indications. In this study the effects of thorax with ginger and mustard flour are investigated under standardized conditions. Heart rate variability, well being, warmth distribution and respiratory activity of healthy subjects will be measured.
详细描述
The purpose of this study is to investigate the effects of different thorax wraps in healthy subjects. Subjects undergo three different interventions (wraps with ginger flour, mustard flour or warm water (placebo)) on three different days. Heart rate variability and respiratory activity is measured for ten minutes before, during (up to 20 minutes) and for ten minutes after each thorax wrap. To investigate the effects on heat development and regulation, photos are taken with a thermographic infrared camera at various moments in time. Participants are asked to fill in questionnaires referring to their subjective perceptions of warmth, bodily warmth distribution and wellbeing. The order of the thorax wrap interventions is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
排除标准
- •Inflectional disease with body temperature > 38 °C. Skin damage on the thorax area Known intolerance or hypersensitivity to mustard or ginger products. Heart failure. Asthma bronchiale. Taking medication with influence on heart rate variability ( mainly tricyclic antidepressants and beta blocker).
- •Consumption of coffee or nicotine less than three hours before the intervention.
- •Pregnancy. Deficient knowledge of the German language.
研究组 & 干预措施
Thorax wrap with ginger flour (Zingiberis Rhizoma plv.)
Thorax wrap with ginger flour, duration max. 20 minutes
干预措施: Zingiberis Rhizoma plv. (Drug)
Thorax wrap with mustard flour (Sinapis nigrea semen)
Thorax wrap with mustard flour, duration max 20 minutes
干预措施: Sinapis nigrea semen (Drug)
Thorax wrap with warm water (placebo)
Thorax wrap with warm water (placebo), duration: 20 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
changes in temperature
时间窗: max. 40 minutes
Temperature (in °Celsius) of feet, lower legs, hands and face measured with a thermographic infrared camera (pre-post-comparison)
Respiratory activity (expiratory CO2 and NO-measurement)
时间窗: max. 40 minutes
Physiological parameters are measured for pre-post comparison.
次要结局
- Basler Mood Questionnaire (BBS)(40 minutes)
- Herdecker Wärmeempfindungs-Fragebogen (HeWef)(40 minutes)
- Warmth perception and skin irritation (NRS)(40 minutes)
- heart rate variability -Parameter (HRV)(Physiological parameters are measured over a period of 40 minutes)