Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa

A

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status

Completed

Conditions

Anorexia Nervosa

Treatments

Other: Mustard
Other: Ginger
Other: Warm water

Study type

Interventional

Funder types

Other

Identifiers

NCT03519698
SWI_05

Details and patient eligibility

About

A randomized, controlled, three-arm study to investigate the effects of footbaths with ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and in healthy, female adolescents on psychophysiological parameters.

Full description

In a cross-over study design, the subjects (21 female patients with Anorexia nervosa, 20 healthy, female controls) receive footbaths with either ginger, mustard or warm water alone in a randomized order with a wash-out period of at least 1-3 days. The effects of each intervention on the objective warmth generation are measured by infrared thermography, whereas the subjective warmth perception is determined by the 'Herdecke warmth perception questionnaire'. All parameters are determined at specified times (t1 = right before, t2 = right after and t3 = 10 minutes following the footbath), which enables an evaluation based on pre-post-comparisons. The statistical analysis comprises analyses of variances based on linear mixed effects models (after checking for carry-over effects).

Enrollment

41 patients

Sex

Female

Ages

12 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Signed informed consent of the parents
  • Age 12-18 years

Exclusion criteria

  • Infectious disease with body temperature above 38 °C
  • Skin damages at the lower legs/feet
  • Known intolerance/ anaphylaxis to mustard or ginger preparations
  • Cardiac arrhythmia
  • Pregnancy
  • Insufficient knowledge of the German language
  • BMI percentile < 10% (for control group)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

41 participants in 3 patient groups, including a placebo group

Warm water
Placebo Comparator group
Description:
12 l footbath with warm water (40 °C)
Treatment:
Other: Warm water
Warm water & Mustard
Experimental group
Description:
12 l footbath with warm water (40 °C) and 80 g mustard flour
Treatment:
Other: Warm water
Other: Mustard
Warm water & Ginger
Experimental group
Description:
12 l footbath with warm water (40 °C) and 80 g ginger flour
Treatment:
Other: Warm water
Other: Ginger

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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