Anorexia NervosaNCT03519698
Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa
A study testing Warm water, Mustard and Ginger in people with Anorexia Nervosa, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Warm water, Mustard and Ginger
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2015to 22 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Signed informed consent of the parents
- Age 12-18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Anorexia Nervosa
- Being tested
- Warm water, Mustard, Ginger
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm waterOther
Footbaths were prepared with 12 liters of warm water (40 °C)
MustardOther
Also called Sinapis nigrea semen
12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
GingerOther
Also called Zingiberis rhizoma
12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)
| Study group | Role | What they receive |
|---|---|---|
| Warm water | Placebo comparator | 12 l footbath with warm water (40 °C) Receives: Other: Warm water |
| Warm water & Mustard | Experimental | 12 l footbath with warm water (40 °C) and 80 g mustard flour Receives: Other: Warm water; Other: Mustard |
| Warm water & Ginger | Experimental | 12 l footbath with warm water (40 °C) and 80 g ginger flour Receives: Other: Warm water; Other: Ginger |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Self-reported warmth perception at both feet assessed with the "Herdecke warmth perception questionnaire" right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8.
Measured: 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
Self-reported warmth perception in the face 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.
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 2-Item Warmth Perception Measure (face) from t1 to t2
Self-reported warmth perception in the face assessed with the "Herdecke warmth perception questionnaire" right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8.
Measured: 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
Self-reported warmth perception at both hands 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.
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 2-Item Warmth Perception Measure (hands) from t1 to t2
Self-reported warmth perception at both hands assessed with the "Herdecke warmth perception questionnaire" right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8.
Measured: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3
Self-reported overall warmth perception assessed with the "Herdecke warmth perception questionnaire" right before (t1) and 10 minutes following the footbath (t3). The item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 4.
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2
Self-reported overall warmth perception assessed with the "Herdecke warmth perception questionnaire" right before (t1) and right after the footbath (t2). The item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 4.
Measured: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (feet) from t1 to t3
Distal skin temperature in °C at both feet measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3).
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (feet) from t1 to t2
Distal skin temperature in °C at both feet measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2).
Measured: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (face) from t1 to t3
Distal skin temperature in °C in the face measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3).
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (face) from t1 to t2
Distal skin temperature in °C in the face measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2).
Measured: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (hands) from t1 to t3
Distal skin temperature in °C at both hands measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3).
Measured: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (hands) from t1 to t2
Distal skin temperature in °C at both hands measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2).
Measured: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start15 Dec 2015
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jan Vagedes, ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Investigators
- Jan Vagedes, Dr., Study director, ARCIM Institute; University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519698
- Sponsor's protocol ID
- SWI_05
- Status last verified
- May 2018
- First submitted
- 12 Jan 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03519698
- Acronym / sponsor ID
- SWI_05
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Warm water | Placebo comparator | Other: Warm water12 l footbath with warm water (40 °C) |
| Warm water & Mustard | Experimental | Other: Warm water, Other: Mustard12 l footbath with warm water (40 °C) and 80 g mustard flour |
| Warm water & Ginger | Experimental | Other: Warm water, Other: Ginger12 l footbath with warm water (40 °C) and 80 g ginger flour |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Signed informed consent of the parents
- Age 12-18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm waterFootbaths were prepared with 12 liters of warm water (40 °C) | Other | Warm water, Warm water & Ginger, Warm water & Mustard |
| MustardAlso: Sinapis nigrea semen12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.) | Other | Warm water & Mustard |
| GingerAlso: Zingiberis rhizoma12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.) | Other | Warm water & Ginger |
Primary outcome
Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
Time frame: right before the footbath (t1) and 10 minutes following the footbath (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.
13 secondary outcomes
Change in 2-Item Warmth Perception Measure (feet) from t1 to t2
Time frame: 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
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 2-Item Warmth Perception Measure (face) from t1 to t2
Time frame: 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
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 2-Item Warmth Perception Measure (hands) from t1 to t2
Time frame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2
Time frame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (feet) from t1 to t3
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (feet) from t1 to t2
Time frame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (face) from t1 to t3
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (face) from t1 to t2
Time frame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Change in Distal Skin Temperature Measure (hands) from t1 to t3
Time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Change in Distal Skin Temperature Measure (hands) from t1 to t2
Time frame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, Dr. study director
ARCIM Institute; University of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm water, Mustard and Ginger in people with Anorexia Nervosa, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 2-Item Warmth Perception Measure (feet) from t1 to t3 (time frame: right before the footbath (t1) and 10 minutes following the footbath (t3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.