NCT02285452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

November 5, 2014

Last Update Submit

May 8, 2018

Conditions

Healthy

Keywords

physiologcal phenomena.HRV Parametersrespiratory activitythorax wraps

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Basler Mood Questionnaire (BBS)

    40 minutes

  • Herdecker Wärmeempfindungs-Fragebogen (HeWef)

    40 minutes

  • Warmth perception and skin irritation (NRS)

    40 minutes

  • heart rate variability -Parameter (HRV)

    Physiological parameters are measured over a period of 40 minutes

  • heart rate variability -Parameter (HRV)

    Physiological parameters are measured over a period of 40 minutes

  • +3 more secondary outcomes

Study Arms (3)

Thorax wrap with ginger flour (Zingiberis Rhizoma plv.)

ACTIVE COMPARATOR

Thorax wrap with ginger flour, duration max. 20 minutes

Drug: Zingiberis Rhizoma plv.

Thorax wrap with mustard flour (Sinapis nigrea semen)

ACTIVE COMPARATOR

Thorax wrap with mustard flour, duration max 20 minutes

Drug: Sinapis nigrea semen

Thorax wrap with warm water (placebo)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zingiberis Rhizoma plv.DRUG
Thorax wrap with ginger flour (Zingiberis Rhizoma plv.)
Sinapis nigrea semenDRUG
Thorax wrap with mustard flour (Sinapis nigrea semen)
PlaceboDRUG
Thorax wrap with warm water (placebo)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Study Officials

  • Jan Vagedes, Dr.

    ARCIM-Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

DE(1)