NCT04321720已完成不适用
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design
ARCIM Institute Academic Research in Complementary and Integrative Medicine1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年4月20日最近更新:
适应症
干预措施
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
- 1
- 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 mustard 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 blinded, four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of mustard 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
- •Varicose veins grade 3 and grade 4 (Marshall stage classification)
- •Chronic venous insufficiency
- •Known intolerance or hypersensitivity to mustard preparations
- •Cardiac arrhythmia
- •Cardiac pacemaker
- •Asthma bronchiale
- •Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
- •Pregnancy
- •Insufficient knowledge of the german language
研究组 & 干预措施
3-g footbath
Experimental
Footbath with 3g mustard flour per liter of water
干预措施: 3-g mustard footbath (Other)
6-g footbath
Experimental
Footbath with 6g mustard flour per liter of water
干预措施: 6-g mustard footbath (Other)
12-g footbath
Experimental
Footbath with 12g mustard flour per liter of water
干预措施: 12-g mustard footbath (Other)
Warm water footbath
Placebo Comparator
Footbath with warm water only
干预措施: Warm water only (Other)
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
- 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))
- Skin surface temperature at the hands at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3))
- Skin surface temperature in the face at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3) (length of footbath is up to 20 minutes))
- Heart rate variability (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(After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up)
- Evening morning protocol: skin condition(After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up)
- 2-item warmth perception measure at the feet at time point 1 (t1) and time point 3 (t3)(Immediately before (time point 1, t1) and 10 minutes following the footbath (time point 3, t3).)
- 2-item warmth perception measure at the hands at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3).)
- 2-item warmth perception measure at the head at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3))
- Evening morning protocol: general well-being(After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up)
- 1-item overall warmth perception measure at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3))
- Warmth perception and skin stimulus at the feet during the footbath(Up to 20 minutes)
- Well-being at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3) (length of footbath is up to 20 minutes))
- Skin surface temperature at the feet at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3))
- Skin surface temperature at the lower legs at t1, t2 and t3(Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3))
- Morning protocol: sleep quality: seven-point rating scale(In the morning after the footbath, within 15 minutes after waking up)
研究者
研究点 (1)
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