Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour

ARCIM Institute Academic Research in Complementary and Integrative Medicine19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Zingiberis Rhizoma plv.DRUG

Sinapis nigrea semenDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

changes in temperature

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

Time frame: max. 40 minutes

Respiratory activity (expiratory CO2 and NO-measurement)

Physiological parameters are measured for pre-post comparison.

Time frame: max. 40 minutes

Secondary Outcomes

Basler Mood Questionnaire (BBS)

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

Time frame: 40 minutes

Herdecker Wärmeempfindungs-Fragebogen (HeWef)

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

Time frame: 40 minutes

Warmth perception and skin irritation (NRS)

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

Time frame: 40 minutes

heart rate variability -Parameter (HRV)

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

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

heart rate variability -Parameter (HRV)

Root Mean Square of the Successive Differences (RMSSD)

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

Data from ClinicalTrials.gov

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