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Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers

A

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status

Completed

Conditions

Thermogenesis by Different-dosage Mustard Flour Footbaths

Treatments

Other: 6-g mustard footbath
Other: Warm water only
Other: 12-g mustard footbath
Other: 3-g mustard footbath

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

16 participants in 4 patient groups, including a placebo group

3-g footbath
Experimental group
Description:
Footbath with 3g mustard flour per liter of water
Treatment:
Other: 3-g mustard footbath
6-g footbath
Experimental group
Description:
Footbath with 6g mustard flour per liter of water
Treatment:
Other: 6-g mustard footbath
12-g footbath
Experimental group
Description:
Footbath with 12g mustard flour per liter of water
Treatment:
Other: 12-g mustard footbath
Warm water footbath
Placebo Comparator group
Description:
Footbath with warm water only
Treatment:
Other: Warm water only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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