Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

NCT03886207 | Completed

• 1 other identifier: ANS_03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

Conditions

Adolescent Anorexia Nervosa

Keywords

Anorexia; Footbath; Ginger powder; Thermogenic substances; Thermoregulation; External applications; Anthroposophic medicine; Eating disorders

Outcome Measures

Primary Outcomes (1)

• Chnge in Subjective feeling of overall warmth

  Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire

  Baseline (pre intervention), 6 weeks after baseline (post intervention)

Secondary Outcomes (55)

• Core body temperature

  Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up

• Face surface temperature

  Baseline (pre intervention) and 6 weeks after baseline (post intervention)

• Feet surface temperature

  Baseline (pre intervention) and 6 weeks after baseline(post intervention)

• Hand surface temperature

  Baseline (pre intervention) and 6 weeks after baseline(post intervention)

• Abdomen surface temperature

  Baseline (pre intervention) and after 6 weeks (post intervention)

Study Arms (2)

Warm water with ginger powder footbath

EXPERIMENTAL

Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.

Other: ginger powder footbath

Warm water only footbath

ACTIVE COMPARATOR

Participants who receive a warm water only footbath four times a week over a six-week period.

Other: warm water only footbath

Interventions

ginger powder footbath OTHER

38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine

Warm water with ginger powder footbath

warm water only footbath OTHER

38-40° C warm water footbath without any additive reaching up to mid-calf level

Warm water only footbath

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• main diagnosis: Anorexia nervosa
• written informed consent of participants and legal guardians

You may not qualify if:

• other eating disorder diagnosis apart from Anorexia nervosa
• known allergic reaction to ginger

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead
• Filderklinik, Filderstadt, Germany: collaborator

Study Sites (1)

ARCIM Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Anorexia; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jan Vagedes, Dr. med.

  ARCIM Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are age and core body temperature stratified and then randomized to one of the two groups (footbath with warm water with additional ginger powder or warm water only). Assessments are taken before and after the six-week intervention phase as well as at six-month follow-up.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: April 8, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 27, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)