Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour (SWI_02)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Zingiberis Rhizoma plv.; Drug: Sinapis nigrea semen

Detailed Description

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
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Filderklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thorax wrap with ginger flour (Zingiberis Rhizoma plv.); Thorax wrap with ginger flour, duration max. 20 minutes	Drug: Zingiberis Rhizoma plv.
Active Comparator: Thorax wrap with mustard flour (Sinapis nigrea semen); Thorax wrap with mustard flour, duration max 20 minutes	Drug: Sinapis nigrea semen
Placebo Comparator: Thorax wrap with warm water (placebo); Thorax wrap with warm water (placebo), duration: 20 minutes	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in temperature	Temperature (in °Celsius) of feet, lower legs, hands and face measured with a thermographic infrared camera (pre-post-comparison)	max. 40 minutes
Respiratory activity (expiratory CO2 and NO-measurement)	Physiological parameters are measured for pre-post comparison.	max. 40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basler Mood Questionnaire (BBS)	filled in by the participants nine times (before and after the thorax wrap and 10 minutes after the intervention)	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)	40 minutes
Warmth perception and skin irritation (NRS)	Warmth perception and skin irritation during the intervention every minute (measured with a numeric rating scale).	40 minutes
heart rate variability -Parameter (HRV)	Standard Deviation of Normal to Normal (heart rate) (SDNN)	Physiological parameters are measured over a period of 40 minutes
heart rate variability -Parameter (HRV)	Root Mean Square of the Successive Differences (RMSSD)	Physiological parameters are measured over a period of 40 minutes
heart rate variability -Parameter (HRV)	ratio low frequency to high frequency (LF/HF)	Physiological parameters are measured over a period of 40 minutes
heart rate variability -Parameter (HRV)	very low frequency (VLF)	Physiological parameters are measured over a period of 40 minutes
heart rate variability -Parameter (HRV)	NN50 (the number of pairs of successive NNs that differ by more than 50 ms)	Physiological parameters are measured over a period of 40 minutes

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Principal Investigator: Jan Vagedes, Dr., ARCIM-Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: physiologcal phenomena; .HRV Parameters; respiratory activity; thorax wraps
• Other Study ID Numbers: SWI_02