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Completed

NCT Number: NCT02285452

Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent.

Exclusion criteria

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.

Treatment and study plan

Zingiberis Rhizoma plv.

Drug

Sinapis nigrea semen

Drug

Placebo

Drug

Primary outcomes

  1. changes in temperature

    Time frame: max. 40 minutes

    Temperature (in °Celsius) of feet, lower legs, hands and face measured with a thermographic infrared camera (pre-post-comparison)

  2. Respiratory activity (expiratory CO2 and NO-measurement)

    Time frame: max. 40 minutes

    Physiological parameters are measured for pre-post comparison.

Secondary outcomes

  1. Basler Mood Questionnaire (BBS)

    Time frame: 40 minutes

    filled in by the participants nine times (before and after the thorax wrap and 10 minutes after the intervention)

  2. Herdecker Wärmeempfindungs-Fragebogen (HeWef)

    Time frame: 40 minutes

    filled in by the participants nine times (before and after the thorax wrap and 10 minutes after the intervention)

  3. Warmth perception and skin irritation (NRS)

    Time frame: 40 minutes

    Warmth perception and skin irritation during the intervention every minute (measured with a numeric rating scale).

  4. heart rate variability -Parameter (HRV)

    Time frame: Physiological parameters are measured over a period of 40 minutes

    Standard Deviation of Normal to Normal (heart rate) (SDNN)

  5. heart rate variability -Parameter (HRV)

    Time frame: Physiological parameters are measured over a period of 40 minutes

    Root Mean Square of the Successive Differences (RMSSD)

  6. heart rate variability -Parameter (HRV)

    Time frame: Physiological parameters are measured over a period of 40 minutes

    ratio low frequency to high frequency (LF/HF)

  7. heart rate variability -Parameter (HRV)

    Time frame: Physiological parameters are measured over a period of 40 minutes

    very low frequency (VLF)

  8. heart rate variability -Parameter (HRV)

    Time frame: Physiological parameters are measured over a period of 40 minutes

    NN50 (the number of pairs of successive NNs that differ by more than 50 ms)

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study title

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

Acronym: SWI_02

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2014
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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