Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour

NCT ID: NCT02285452

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Thorax wrap with ginger flour (Zingiberis Rhizoma plv.)

Thorax wrap with ginger flour, duration max. 20 minutes

Group Type ACTIVE_COMPARATOR

Zingiberis Rhizoma plv.

Intervention Type DRUG

Thorax wrap with mustard flour (Sinapis nigrea semen)

Thorax wrap with mustard flour, duration max 20 minutes

Group Type ACTIVE_COMPARATOR

Sinapis nigrea semen

Intervention Type DRUG

Thorax wrap with warm water (placebo)

Thorax wrap with warm water (placebo), duration: 20 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Zingiberis Rhizoma plv.

Intervention Type DRUG

Sinapis nigrea semen

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes, Dr.

Role: PRINCIPAL_INVESTIGATOR

ARCIM-Institute

Locations

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Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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SWI_02

Identifier Type: -

Identifier Source: org_study_id

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