Clinical Trials Directory

Trials / Completed

CompletedNCT03519698

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

Efficacy of Footbaths With Ginger, Mustard & Warm Water Only on Psychophysiological Parameters in Female Adolescents With & Without Anorexia Nervosa - a Randomized, Controlled, Three-arm Study With Cross-over Design

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine · Academic / Other
Sex
Female
Age
12 Years – 18 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
OTHERWarm waterFootbaths were prepared with 12 liters of warm water (40 °C)
OTHERMustard12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
OTHERGinger12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)

Timeline

Start date
2015-12-15
Primary completion
2017-06-22
Completion
2017-06-22
First posted
2018-05-09
Last updated
2018-05-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03519698. Inclusion in this directory is not an endorsement.