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

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

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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