Status:

COMPLETED

Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers

Lead Sponsor:

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborating Sponsors:

University Hospital Tuebingen

Conditions:

Thermogenesis by Different-dosage Mustard Flour Footbaths

Eligibility:

All Genders

18-55 years

Phase:

NA

Brief Summary

A study to explore whether different dosages of mustard flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

Detailed Description

This is a blinded, four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of mustard flour in healthy volunteers, comp...

Eligibility Criteria

Inclusion

  • Written informed consent;
  • Age between 18 and 55 years

Exclusion

  • Chronic skin lesions at the lower legs or feet
  • Varicose veins grade 3 and grade 4 (Marshall stage classification)
  • Chronic venous insufficiency
  • Known intolerance or hypersensitivity to mustard preparations
  • Cardiac arrhythmia
  • Cardiac pacemaker
  • Asthma bronchiale
  • Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
  • Pregnancy
  • Insufficient knowledge of the german language

Key Trial Info

Start Date :

April 20 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 26 2020

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04321720

Start Date

April 20 2020

End Date

August 26 2020

Last Update

September 21 2020

Active Locations (1)

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Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany, 70794