NCT03519698

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

January 12, 2018

Last Update Submit

May 8, 2018

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Change in 2-Item Warmth Perception Measure (feet) from t1 to t3

    Self-reported warmth perception at both feet assessed with the "Herdecke warmth perception questionnaire" right before (t1) and 10 minutes following the footbath (t3). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8.

    right before the footbath (t1) and 10 minutes following the footbath (t3)

Secondary Outcomes (13)

  • Change in 2-Item Warmth Perception Measure (feet) from t1 to t2

    right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)

  • Change in 2-Item Warmth Perception Measure (face) from t1 to t3

    right before the footbath (t1) and 10 minutes following the footbath (t3)

  • Change in 2-Item Warmth Perception Measure (face) from t1 to t2

    right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)

  • Change in 2-Item Warmth Perception Measure (hands) from t1 to t3

    right before the footbath (t1) and 10 minutes following the footbath (t3)

  • Change in 2-Item Warmth Perception Measure (hands) from t1 to t2

    right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)

  • +8 more secondary outcomes

Study Arms (3)

Warm water

PLACEBO COMPARATOR

12 l footbath with warm water (40 °C)

Other: Warm water

Warm water & Mustard

EXPERIMENTAL

12 l footbath with warm water (40 °C) and 80 g mustard flour

Other: Warm waterOther: Mustard

Warm water & Ginger

EXPERIMENTAL

12 l footbath with warm water (40 °C) and 80 g ginger flour

Other: Warm waterOther: Ginger

Interventions

Warm waterOTHER

Footbaths were prepared with 12 liters of warm water (40 °C)

Warm waterWarm water & GingerWarm water & Mustard
MustardOTHER

12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)

Also known as: Sinapis nigrea semen
Warm water & Mustard
GingerOTHER

12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)

Also known as: Zingiberis rhizoma
Warm water & Ginger

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Aminesginger extract

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Jan Vagedes, Dr.

    ARCIM Institute; University of Tuebingen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

January 12, 2018

First Posted

May 9, 2018

Study Start

December 15, 2015

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

DE(1)