Adolescent Anorexia NervosaNCT03886207
Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths
A study testing ginger powder footbath and warm water only footbath in people with Adolescent Anorexia Nervosa, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years, women only
- Conditions the study is for
- Adolescent Anorexia Nervosa
- What is being tested?
- ginger powder footbath and warm water only footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2019to 27 Feb 2020
- 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 8 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- main diagnosis: Anorexia nervosa
- written informed consent of participants and legal guardians
Who cannot join
- other eating disorder diagnosis apart from Anorexia nervosa
- known allergic reaction to ginger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study
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.
Read the 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
- Being tested
- ginger powder footbath, warm water only footbath
- Keywords
- Anorexia, Footbath, Ginger powder, Thermogenic substances, Thermoregulation, External applications, Anthroposophic medicine, Eating disorders
- Medical subject headings
- Anorexia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginger powder footbathOther
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 footbathOther
38-40° C warm water footbath without any additive reaching up to mid-calf level
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: warm water only footbath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Secondary outcomes (55)
Core body temperature
Core body temperature measured using an infrared tympanical thermometer as used in clinical routine
Measured: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
Face surface temperature
Surface temperature in the face measured using high-resolution infrared thermography
Measured: Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Feet surface temperature
Surface temperature at the feet measured using high-resolution infrared thermography
Measured: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Hand surface temperature
Surface temperature on the hands measured using high-resolution infrared thermography
Measured: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Abdomen surface temperature
Surface temperature at the abdomen measured using high-resolution infrared thermography
Measured: Baseline (pre intervention) and after 6 weeks (post intervention)
24-hour feet surface temperature
24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM)
Measured: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
24-hour hand surface temperature
24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM)
Measured: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour abdomen surface temperature
24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM)
Measured: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour torso surface temperature
24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM)
Measured: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
Body Mass Index
Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)^2〗
Measured: Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
Pulse Transit Time (PTT)
PTT in ms, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Perfusion Index (PI)
PI, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Peak to Peak Time (PPT)
Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SlopeInW1
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
SlopeInW2
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW3
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW4
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Stiffness Index
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Reflection Index
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTX
TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTY
TimeTY in ms, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTYTX
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAX
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
AreaAY
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAYAX
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAV
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAW
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAWAV
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTVTW
Measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTV
TimeTV in ms, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTW
TimeTW in ms, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT1
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT2
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
MaxT1
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MaxT2
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotHRRespRate
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Heart rate
beats per minute (bpm) measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Respiratory rate
measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SDNN (standard deviation of normal to normal)
Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
RMSSD (Root mean square of successive differences)
Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
pNN50
Number of pairs of successive heart rate intervals that differ by more than 50 ms
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
HF (high frequency)
Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
LF (low frequency)
Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
LF/HF-Ratio
Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), measured with the GeTeMed Vitaguard 3100
Measured: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Pittsburgh sleep quality index
Scores of the PSQI (Pittsburgh sleep quality index)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Inventory -2
Scores of the EDI-2 (Eating Disorder Inventory)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Examination- Questionnaire
Scores of the EDE-Q (Eating Disorder Examination)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Becks Depressions Inventar
Scores of the BDI-II (Becks Depression Inventar)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Anxiety
Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Depression
Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Body Image State Scale
Mean of all six item values (range from 0-9) with higher values indicating a positive body image state of the BISS (Body Image State Scale)
Measured: Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up
Positive And Negative Affect Schedule
Scores of the PANAS-X (Positive and negative affect schedule)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Short Form Health Survey 12
Scores of the SF-12 (Short Form 12)
Measured: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Basler Befindlichkeits Skala
Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire)
Measured: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up
Body Shape Questionnaire
Scores of the BSQ (Body Shape Questionnaire)
Measured: Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start8 Apr 2019
- Primary completion26 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Filderklinik, Filderstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr. med., Principal investigator, ARCIM Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886207
- Sponsor's protocol ID
- ANS_03
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03886207
- Acronym / sponsor ID
- ANS_03
- Conditions
- Adolescent Anorexia Nervosa
- Keywords
- Anorexia, Footbath, Ginger powder, Thermogenic substances, Thermoregulation, External applications, Anthroposophic medicine, Eating disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- Filderklinik, Filderstadt, Germany
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 22 Mar 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Warm water with ginger powder footbath | Experimental | Other: ginger powder footbathParticipants who receive a warm water with added ginger powder footbath four times a week over a six-week period. |
| Warm water only footbath | Active comparator | Other: warm water only footbathParticipants who receive a warm water only footbath four times a week over a six-week period. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- main diagnosis: Anorexia nervosa
- written informed consent of participants and legal guardians
Key exclusion criteria (2 listed)
- other eating disorder diagnosis apart from Anorexia nervosa
- known allergic reaction to ginger
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 |
|---|---|---|
| ginger powder footbath38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine | Other | Warm water with ginger powder footbath |
| warm water only footbath38-40° C warm water footbath without any additive reaching up to mid-calf level | Other | Warm water only footbath |
Primary outcome
Chnge in Subjective feeling of overall warmth
Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire
55 secondary outcomes
Core body temperature
Time frame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
Face surface temperature
Time frame: Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Feet surface temperature
Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Hand surface temperature
Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Abdomen surface temperature
Time frame: Baseline (pre intervention) and after 6 weeks (post intervention)
24-hour feet surface temperature
Time frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
24-hour hand surface temperature
Time frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour abdomen surface temperature
Time frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour torso surface temperature
Time frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
Body Mass Index
Time frame: Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
Pulse Transit Time (PTT)
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Perfusion Index (PI)
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Peak to Peak Time (PPT)
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SlopeInW1
Time frame: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
SlopeInW2
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW3
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW4
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Stiffness Index
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Reflection Index
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTX
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTY
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTYTX
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAX
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
AreaAY
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAYAX
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAV
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAW
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAWAV
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTVTW
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTV
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTW
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT1
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT2
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
MaxT1
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MaxT2
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotHRRespRate
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Heart rate
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Respiratory rate
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SDNN (standard deviation of normal to normal)
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
RMSSD (Root mean square of successive differences)
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
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 21 Jul 2020.
- Individual participant dataSharing planned: No
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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. med. principal investigator
ARCIM Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ginger powder footbath and warm water only footbath in people with Adolescent 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 2 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 21 Jul 2020. 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. 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?
Chnge in Subjective feeling of overall warmth (time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention)). 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 21 Jul 2020.