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

NCT ID: NCT03886207

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2020-02-27

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.

Detailed Description

This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

Conditions

Adolescent Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Warm water with ginger powder footbath

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

Group Type: EXPERIMENTAL

ginger powder footbath

Intervention Type: 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 only footbath

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

Group Type: ACTIVE_COMPARATOR

warm water only footbath

Intervention Type: OTHER

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

Interventions

ginger powder footbath

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

Intervention Type: OTHER

warm water only footbath

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Filderklinik, Filderstadt, Germany

UNKNOWN

Sponsor Role: collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

ARCIM Institute

Locations

ARCIM Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

ANS_03

Identifier Type: -

Identifier Source: org_study_id