NCT04051476已完成不适用
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design
ARCIM Institute Academic Research in Complementary and Integrative Medicine2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- 2-item warmth perception measure at the feet after the footbath
研究概览
简要总结
A study to explore whether different dosages of ginger flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.
详细描述
This is a four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of ginger flour in healthy volunteers, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age between 18 and 55 years
排除标准
- •Chronic skin lesions at the lower legs or feet
- •Known intolerance or hypersensitivity to ginger preparations
- •Cardiac arrhythmia
- •Cardiac pacemaker
- •Asthma bronchiale
- •Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
- •Pregnancy
- •Insufficient knowledge of the german language
结局指标
主要结局
2-item warmth perception measure at the feet after the footbath
时间窗: Immediately after the footbath, timepoint 2 (t2)
Self-reported warmth perception at both feet, assessed with the "Herdecke warmth perception questionnaire" immediately after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
次要结局
- Well-being at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- 2-item warmth perception measure at the feet at t1 and t3(Immediately before (t1) and 10 minutes following the footbath (t3))
- 2-item warmth perception measure at the hands at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).)
- Skin surface temperature at the lower legs at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- 1-item overall warmth perception measure at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- 2-item warmth perception measure at the head at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- HRV analysis: SDNN(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- Warmth perception and skin stimulus at the feet during the footbath(Up to 20 minutes)
- Skin surface temperature at the feet at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- Skin surface temperature at the hands at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- Evening morning protocol: skin condition(On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up)
- Evening morning protocol: general well-being(On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up)
- Morning protocol: sleep quality(In the morning after the footbath, within 15 minutes after waking up)
- Skin surface temperature in the face at t1, t2 and t3(Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3))
- HRV analysis: HF(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- HRV analysis: LF(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- HRV analysis: LF/HF ratio(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- HRV analysis: RMSSD(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- HRV analysis: pNN50(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- Pulse wave analysis: Pulse Transit Time(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- Pulse wave analysis: Reflection Index(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- Pulse wave analysis: Perfusion Index(Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period))
- Evening morning protocol: perception of warmth and stimulus at the feet(On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Dose-response Relationship of Mustard Flour Footbaths in Healthy VolunteersThermogenesis by Different-dosage Mustard Flour FootbathsNCT04321720ARCIM Institute Academic Research in Complementary and Integrative Medicine16
已完成
不适用
Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of SleepNonorganic InsomniaNCT04210895ARCIM Institute Academic Research in Complementary and Integrative Medicine29
已完成
不适用
Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water FootbathsAdolescent Anorexia NervosaNCT03886207ARCIM Institute Academic Research in Complementary and Integrative Medicine24
已完成
不适用
Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological DiseaseOncologic DisordersNCT04271670ARCIM Institute Academic Research in Complementary and Integrative Medicine36
已完成
不适用
Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia NervosaAnorexia NervosaNCT03519698ARCIM Institute Academic Research in Complementary and Integrative Medicine41